Chapter 2 General Analytical Operations and Information
operation capability analysis
operation capability analysis Operation capability analysis is a vital tool used in business operations to evaluate an organization's ability to deliver products or services efficiently and effectively. By assessing the organization's capacity, resources, processes, and systems, operation capability analysis provides valuable insights for decision-making and improving overall operational performance. In this article, we will delve into the details of operation capability analysis, exploring its importance, steps involved, and benefits.First and foremost, it is essential to understand the significance of operation capability analysis. In today's dynamic business environment, organizations face numerous challenges, including competition, changing customer demands, technological advancements, and economic uncertainties. It is crucial for businesses to have a clear understanding of their operational capabilities to identify areas of improvement and stay competitive. Operation capability analysis helps organizations identify their strengths and weaknesses, prioritize improvement areas, and allocate resources effectively.Now, let's proceed with the steps involved in operation capabilityanalysis:1. Identification of key operational areas: The first step in operation capability analysis is to identify the key operational areas that are crucial for the organization's success. These could include production, supply chain, distribution, customer service, or any other area specific to the organization's industry and objectives.2. Gathering relevant data: Once the key operational areas are identified, data related to each area needs to be collected. This data may include operational metrics, performance indicators, customer feedback, employee feedback, and financial information. The data should be collected from reliable and relevant sources to ensure accuracy and validity.3. Analysis of data: The collected data is then analyzed using various analytical techniques. Statistical tools, such as regression analysis, trend analysis, and benchmarking, can be used to identify patterns, trends, and areas of improvement. The analysis should focus on both quantitative and qualitative aspects of the data to gain a comprehensive understanding of the organization's operational capabilities.4. Identifying strengths and weaknesses: Based on the analysis, the organization's strengths and weaknesses in each operational area are identified. This helps in understanding the areas where the organization excels and those that require improvement. It is crucial to involve key stakeholders, such as managers, employees, and customers, in this step to gain diverse perspectives and insights.5. Setting improvement goals: Once the strengths and weaknesses are identified, improvement goals are set for each operational area. These goals should be specific, measurable, achievable, relevant, and time-bound (SMART). The goals should align with the organization's overall objectives and consider external factors, such as market trends and competitive landscape.6. Developing an action plan: An action plan is developed to achieve the improvement goals. The plan should outline specific tasks, responsibilities, timelines, and required resources. It should consider any constraints or limitations and prioritize the most critical improvement areas. The action plan should be communicated effectively to ensure alignment and accountabilityacross the organization.7. Monitoring and measuring progress: Regular monitoring and measurement of progress are essential to track the effectiveness of the action plan. Key performance indicators (KPIs) are established to measure the organization's performance against the improvement goals. Progress reports, feedback mechanisms, and periodic reviews are conducted to ensure that the organization stays on track and takes corrective actions if necessary.Now that we have covered the steps involved in operation capability analysis, let's discuss the benefits.1. Improved operational efficiency: Operation capability analysis helps organizations identify bottlenecks, inefficiencies, and redundant processes, leading to improved operational efficiency. By streamlining processes, optimizing resources, and eliminating waste, organizations can reduce costs and enhance productivity.2. Enhanced customer satisfaction: Through operation capability analysis, organizations can identify areas that directly impact customer satisfaction. By focusing on these areas, organizationscan meet customer expectations, improve product/service quality, and provide a better customer experience.3. Strategic decision-making: Operation capability analysis providesa data-driven approach to decision-making. By understanding the organization's operational capabilities, management can make informed decisions regarding resource allocation, process improvements, investments, and strategic initiatives.4. Competitive advantage: Operation capability analysis helps organizations identify unique strengths and differentiators that set them apart from competitors. By leveraging these strengths and improving weaknesses, organizations can gain a competitive advantage in the marketplace.In conclusion, operation capability analysis is a valuable tool that helps organizations understand their operational strengths and weaknesses. By following a structured approach to analyze data, identify improvement areas, and develop action plans, organizations can enhance operational efficiency, improve customer satisfaction, make strategic decisions, and gain acompetitive edge. Continuous monitoring and measurement of progress ensure that organizations stay on track and achieve their operational improvement goals.。
分析化学专业英语词汇
precipitation method volatilization method constituent insoluble volatility weight loss interference
calibration 校准 widespread 分布广泛的, 普遍的 gravimetric method重量分析法 volumetric method容量法 concentration 浓度 titration 滴定 back-titration 反滴定
analytical chemical term
elucidation balance quantitative measurement notion philosophical
abstraction抽象 analytical method 分析方法 rely upon 依赖 aspire to 渴望 specialization 专业化 prospective 预期的，未来的
The normal boiling point is the boiling point at 760 Torr, the atomspheric pressure at sea level. It is possible for a liquid to be superheated - heated to a temperature above the boiling point without the occurrence of boiling.
二、 词汇（New Words and Expressions）
analytical chemical term 分析化学术语 elucidation说明, 阐明 balance 天平, 秤 quantitative measurement 定量测量 notion 概念, 观念, 想法 philosophical 哲学的
欧洲药典8.0-凡例双语版
1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the European Pharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。
The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatoryStates of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。
In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph.Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写 Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using themonograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
第二章chapter2
Chapter2Transformations and Vectors2.1Change of BasisLet us reconsider the vectorx=(2,1,3).Fully written out in a given Cartesian frame e i(i=1,2,3),it isx=2e1+e2+3e3.(This is one of the few times we do not use i as the symbol for a Cartesian frame vector.)Suppose we appoint a new frame˜e i(i=1,2,3)such thate1=˜e1+2˜e2+3˜e3,e2=4˜e1+5˜e2+6˜e3,e3=7˜e1+8˜e2+9˜e3.From these expansions we could calculate the˜e i and verify that they are non-coplanar.As x is an objective,frame-independent entity,we can write x=2(˜e1+2˜e2+3˜e3)+(4˜e1+5˜e2+6˜e3)+3(7˜e1+8˜e2+9˜e3)=(2+4+21)˜e1+(4+5+24)˜e2+(6+6+27)˜e3=27˜e1+33˜e2+39˜e3.In these calculations it is unimportant whether the frames are Cartesian; it is important only that we have the table of transformation⎛⎝123 456 789⎞⎠.1112Tensor Analysis with Applications in MechanicsIt is clear that we can repeat the same operation in general form.Let x be of the formx=3i=1x i e i(2.1)with the table of transformation of the frame given ase i=3j=1A ji˜e j.Thenx=3i=1x i3j=1A ji˜e j=3j=1˜e j3i=1A jix i.So in the new basis we havex=3j=1˜x j˜e j where˜x j=3i=1A jix i.Here we have introduced a new notation,placing some indices as subscripts and some as superscripts.Although this practice may seem artificial,there are fairly deep reasons for following it.2.2Dual BasesTo perform operations with a vector x,we must have a straightforward method of calculating its components—ultimately,no matter how ad-vanced we are,we must be able to obtain the x i using simple arithmetic. We prefer formulas that permit us tofind the components of vectors using dot multiplication only;we shall need these when doing frame transfor-mations,etc.In a Cartesian frame the necessary operation is simple dot multiplication by the corresponding basis vector of the frame:we havex k=x·i k(k=1,2,3).This procedure fails in a more general non-Cartesian frame where we do not necessarily have e i·e j=0for all j=i.However,it may still be possible tofind a vector e i such thatx i=x·e i(i=1,2,3)Transformations and Vectors 13in this more general situation.If we set x i =x ·e i =⎛⎝3 j =1x j e j ⎞⎠·e i =3 j =1x j (e j ·e i )and compare the left-and right-hand sides,we see that equality holds whene j ·e i =δi j (2.2)whereδi j = 1,j =i,0,j =i,is the Kronecker delta symbol.In a Cartesian frame we havee k =e k =i kfor each k .Exercise 2.1.Show that e i is determined uniquely by the requirement that x i =x ·e i for every x .Now let us discuss the geometrical nature of the vectors e i .Consider,for example,the equations for e 1:e 1·e 1=1,e 2·e 1=0,e 3·e 1=0.We see that e 1is orthogonal to both e 2and e 3,and its magnitude is such that e 1·e 1=1.Similar properties hold for e 2and e 3.Exercise 2.2.Show that the vectors e i are linearly independent.By Exercise 2.2,the e i constitute a frame or basis.This basis is said to be reciprocal or dual to the basis e i .We can therefore expand an arbitrary vector x asx =3i =1x i e i .(2.3)Note that superscripts and subscripts continue to appear in our notation,but in a way complementary to that used in equation (2.1).If we dot-multiply the representation (2.3)of x by e j and use (2.2)we get x j .This explains why the frames e i and e i are dual:the formulasx ·e i =x i ,x ·e i =x i ,14Tensor Analysis with Applications in Mechanicslook quite similar.So the introduction of a reciprocal basis gives many potential advantages.Let us discuss the reciprocal basis in more detail.Thefirst problem is tofind suitable formulas to define it.We derive these formulas next, butfirst let us note the following.The use of reciprocal vectors may not be practical in those situations where we are working with only two or three vectors.The real advantages come when we are working intensively with many vectors.This is reminiscent of the solution of a set of linear simultaneous equations:it is inefficient tofind the inverse matrix of the system if we have only one forcing vector.But when we must solve such a problem repeatedly for many forcing vectors,the calculation and use of the inverse matrix is reasonable.Writing out x in the e i and e i bases,we used a combination of indices (i.e.,subscripts and superscripts)and summation symbols.From now on we shall omit the symbol of summation when we meet matching subscripts and superscripts:we shall write,say,x i a i.x i a i for the sumiThat is,whenever we see i as a subscript and a superscript,we shall under-stand that a summation is to be carried out over i.This rule shall apply to situations involving vectors as well:we shall understand,for example,x i e i.x i e i to mean the summationiThis rule is called the rule of summation over repeated indices.1Note that a repeated index is a dummy index in the sense that it may be replaced by any other index not already in use:we havex i a i=x1a1+x2a2+x3a3=x k a kfor instance.An index that occurs just once in an expression,for example the index i inA k i x k,is called a free index.In tensor discussions each free index is understood to range independently over a set of values—presently this set is{1,2,3}. 1The rule of summation wasfirst introduced not by mathematicians but by Einstein, and is sometimes referred to as the Einstein summation convention.In a paper where he introduced this rule,Einstein used Cartesian frames and therefore did not distinguish superscripts from subscripts.However,we shall continue to make the distinction so that we can deal with non-Cartesian frames.Transformations and Vectors15 Let us return to the task of deriving formulas for the reciprocal basis vectors e i in terms of the original basis vectors e i.We construct e1first. Since the cross product of two vectors is perpendicular to both,we can satisfy the conditionse2·e1=0,e3·e1=0,by settinge1=c1(e2×e3)where c1is a constant.To determine c1we requiree1·e1=1.We obtainc1[e1·(e2×e3)]=1.The quantity e1·(e2×e3)is a scalar whose absolute value is the volume of the parallelepiped described by the vectors e i.Denoting it by V,we havee1=1V(e2×e3).Similarly,e2=1V(e3×e1),e3=1V(e1×e2).The reader may verify that these expressions satisfy(2.2).Let us mention that if we construct the reciprocal basis to the basis e i we obtain the initial basis e i.Hence we immediately get the dual formulase1=1V(e2×e3),e2=1V(e3×e1),e3=1V(e1×e2),whereV =e1·(e2×e3).Within an algebraic sign,V is the volume of the parallelepiped described by the vectors e i.Exercise2.3.Show that V =1/V.Let us now consider the forms of the dot product between two vectorsa=a i e i=a j e j,b=b p e p=b q e q.16Tensor Analysis with Applications in MechanicsWe havea·b=a i e i·b p e p=a i b p e i·e p.Introducing the notationg ip=e i·e p,(2.4) we havea·b=a i b p g ip.(As a short exercise the reader should write out this expression in full.) Using the reciprocal component representations we geta·b=a j e j·b q e q=a j b q g jqwhereg jq=e j·e q.(2.5) Finally,using a mixed representation we geta·b=a i e i·b q e q=a i b qδq i=a i b iand,similarly,a·b=a j b j.Hencea·b=a i b j g ij=a i b j g ij=a i b i=a i b i.We see that when we use mixed bases to represent a and b we get formulas that resemble the equationa·b=a1b1+a2b2+a3b3from§1.3;otherwise we get more terms and additional multipliers.We will encounter g ij and g ij often.They are the components of a unique tensor known as the metric tensor.In Cartesian frames we obviously haveg ij=δj,g ij=δi j.iTransformations and Vectors17 2.3Transformation to the Reciprocal FrameHow do the components of a vector x transform when we change to the reciprocal frame?We simply setx i e i=x i e iand dot both sides with e j to getx i e i·e j=x i e i·e jorx j=x i g ij.(2.6) In the system of equations⎛⎝x1x2x3⎞⎠=⎛⎝g11g21g31g12g22g32g13g23g33⎞⎠⎛⎝x1x2x3⎞⎠the matrix of the components of the metric tensor g ij is also called the Gram matrix.A theorem in linear algebra states that its determinant is not zero if and only if the vectors e i are linearly independent.Exercise2.4.(a)Show that if the Gram determinant vanishes,then the e i are linearly dependent.(b)Prove that the Gram determinant equals V2.We called the basis e i dual to the basis e i.In e i the metric components are given by g ij,so we can immediately write an expression dual to(2.6):x i=x j g ij.(2.7)We see from(2.6)and(2.7)that,using the components of the metric tensor, we can always change subscripts to superscripts and vice versa.These actions are known as the raising and lowering of indices.Finally,(2.6)and (2.7)together implyx i=g ij g jk x k,henceg ij g jk=δk i.Of course,this means that the matrices of g ij and g ij are mutually inverse.18Tensor Analysis with Applications in MechanicsQuick summaryGiven a basis e i,the vectors e i given by the requirement thate j·e i=δi jare linearly independent and form a basis called the reciprocal or dual basis. The definition of dual basis is motivated by the equation x i=x·e i.The e i can be written ase i=1V(e j×e k)where the ordered triple(i,j,k)equals(1,2,3)or one of the cyclic permu-tations(2,3,1)or(3,1,2),and whereV=e1·(e2×e3).The dual of the basis e k(i.e.,the dual of the dual)is the original basis e k.A given vector x can be expressed asx=x i e i=x i e iwhere the x i are the components of x with respect to the dual basis. Exercise2.5.(a)Let x=x k e k=x k e k.Write out the modulus of x in all possible forms using the metric tensor.(b)Write out all forms of the dot product x·y.2.4Transformation Between General FramesHaving transformed the components x i of a vector x to the corresponding components x i relative to the reciprocal basis,we are now ready to take on the more general task of transforming the x i to the corresponding compo-nents˜x i relative to any other basis˜e i.Let the new basis˜e i be related to the original basis e i bye i=A ji˜e j.(2.8) This is,of course,compact notation for the system of equations⎛⎝e1e2e3⎞⎠=⎛⎝A11A21A31A12A22A32A13A23A33⎞⎠≡A,say⎛⎝˜e1˜e2˜e3⎞⎠.Transformations and Vectors19the subscript indexes Before proceeding,we note that in the symbol A jithe row number in the matrix A,while the superscript indexes the column number.Throughout our development we shall often take the time to write various equations of interest in matrix notation.It follows from(2.8)that=e i·˜e j.A jiExercise2.6.A Cartesian frame is rotated about its third axis to give a new Cartesian frame.Find the matrix of transformation.A vector x can be expressed in the two formsx=x k e k,x=˜x i˜e i.Equating these two expressions for the same vector x,we have˜x i˜e i=x k e k,hence˜e j.(2.9)˜x i˜e i=x k A jkTofind˜x i in terms of x i,we may expand the notation and write(2.9)as ˜x1˜e1+˜x2˜e2+˜x3˜e3=x1A j1˜e j+x2A j2˜e j+x3A j3˜e jwhere,of course,A j1˜e j=A11˜e1+A21˜e2+A31˜e3,A j2˜e j=A12˜e1+A22˜e2+A32˜e3,A j3˜e j=A13˜e1+A23˜e2+A33˜e3.Matching coefficients of the˜e i wefind˜x1=x1A11+x2A12+x3A13=x j A1j,˜x2=x1A21+x2A22+x3A23=x j A2j,˜x3=x1A31+x2A32+x3A33=x j A3j,hence˜x i=x j A i j.(2.10) It is possible to obtain(2.10)from(2.9)in a succinct manner.On the right-hand side of(2.9)the index j is a dummy index which we can replace with20Tensor Analysis with Applications in Mechanicsi and thereby obtain(2.10)immediately.The matrix notation equivalent of(2.10)is⎛⎝˜x1˜x2˜x3⎞⎠=⎛⎝A11A12A13A21A22A23A31A32A33⎞⎠⎛⎝x1x2x3⎞⎠and thus involves multiplication by A T,the transpose of A.We shall also need the equations of transformation from the frame˜e i back to the frame e i.Since the direct transformation is linear the inverse must be linear as well,so we can write˜e i=˜A jie j(2.11) where˜A ji=˜e i·e j.Let usfind the relation between the matrices of transformation A and˜A. By(2.11)and(2.8)we have˜e i=˜A ji e j=˜A jiA k j˜e k,and since the˜e i form a basis we must have˜A jiA k j=δk i. The relationshipA ji ˜A kj=δk ifollows similarly.The product of the matrices(˜A ji)and(A k j)is the unit matrix and thus these matrices are mutually inverse.Exercise2.7.Show that x i=˜x k˜A ik.Formulas for the relations between reciprocal bases can be obtained as follows.We begin with the obvious identitiese j(e j·x)=x,˜e j(˜e j·x)=x.Putting x=˜e i in thefirst of these gives˜e i=A i j e j,while the second identity with x=e i yieldse i=˜A i j˜e j.From these follow the transformation formulas˜x i=x k˜A k i,x i=˜x k A k i.2.5Covariant and Contravariant ComponentsWe have seen that if the basis vectors transform according to the relatione i=A ji˜e j,then the components x i of a vector x must transform according tox i=A ji˜x j.The similarity in form between these two relations results in the x i being termed the covariant components of the vector x.On the other hand,the transformation lawx i=˜A i j˜x jshows that the x i transform like the e i.For this reason the x i are termed the contravariant components of x.We shallfind a further use for this nomenclature in Chapter3.Quick summaryIf frame transformationse i=A ji˜e j,˜e i=˜A ji e j,e i=˜A i j˜e j,˜e i=A ije j,are considered,then x has the various expressionsx=x i e i=x i e i=˜x i˜e i=˜x i˜e i and the transformation lawsx i=A ji˜x j,˜x i=˜A ji x j,x i=˜A i j˜x j,˜x i=A i j x j,apply.The x i are termed contravariant components of x,while the x i are termed covariant components.The transformation laws are particularly simple when the frame is changed to the dual frame.Thenx i=g ji x j,x i=g ij x j,whereg ij=e i·e j,g ij=e i·e j,are components of the metric tensor.2.6The Cross Product in Index NotationIn mechanics a major role is played by the quantity called torque.This quantity is introduced in elementary physics as the product of a force mag-nitude and a length(“force times moment arm”),along with some rules for algebraic sign to account for the sense of rotation that the force would encourage when applied to a physical body.In more advanced discussions in which three-dimensional problems are considered,torque is regarded as a vectorial quantity.If a force f acts at a point which is located relative to an origin O by position vector r,then the associated torque t about O is normal to the plane of the vectors r and f.Of the two possible unit normals,t is conventionally(but arbitrarily)associated with the vectorˆn given by the familiar right-hand rule:if the forefinger of the right hand is directed along r and the middlefinger is directed along f,then the thumb indicates the direction ofˆn and hence the direction of t.The magnitude of t equals|f||r|sinθ,whereθis the smaller angle between f and r.These rules are all encapsulated in the brief symbolismt=r×f.The definition of torque can be taken as a model for a more general operation between vectors:the cross product.If a and b are any two vectors,we definea×b=ˆn|a||b|sinθwhereˆn andθare defined as in the case of torque above.Like any other vector,c=a×b can be expanded in terms of a basis;we choose the reciprocal basis e i and writec=c i e i.Because the magnitudes of a and b enter into a×b in multiplicative fashion, we are prompted to seek c i in the formc i= ijk a j b k.(2.12) Here the ’s are formal coefficients.Let usfind them.We writea=a j e j,b=b k e k,and employ the well-known distributive property(u+v)×w≡u×w+v×wto obtainc =a j e j ×b k e k =a j b k (e j ×e k ).Thenc ·e i =c m e m ·e i =c i =a j b k [(e j ×e k )·e i ]and comparison with (2.12)shows thatijk =(e j ×e k )·e i .Now the value of (e j ×e k )·e i depends on the values of the indices i,j,k .Here it is convenient to introduce the idea of a permutation of the ordered triple (1,2,3).A permutation of (1,2,3)is called even if it can be brought about by performing any even number of interchanges of pairs of these numbers;a permutation is odd if it results from performing any odd number of interchanges.We saw before that (e j ×e k )·e i equals the volume of the frame parallelepiped if i,j,k are distinct and the ordered triple (i,j,k )is an even permutation of (1,2,3).If i,j,k are distinct and the ordered triple (i,j,k )is an odd permutation of (1,2,3),we obtain minus the volume of the frame parallelepiped.If any two of the numbers i,j,k are equal we obtain zero.Hence ijk =⎧⎪⎪⎨⎪⎪⎩+V,(i,j,k )an even permutation of (1,2,3),−V,(i,j,k )an odd permutation of (1,2,3),0,two or more indices equal.Moreover,it can be shown (Exercise 2.4)thatV 2=gwhere g is the determinant of the matrix formed from the elements g ij =e i ·e j of the metric tensor.Note that |V |=1for a Cartesian frame.The permutation symbol ijk is useful in writing formulas.For example,the determinant of a matrix A =(a ij )can be expressed succinctly asdet A = ijk a 1i a 2j a 3k .Much more than a notational device however, ijk represents a tensor (the so-called Levi–Civita tensor ).We discuss this further in Chapter 3.Exercise 2.8.The contravariant components of a vector c =a ×b can be expressed asc i = ijk a j b kfor suitable coefficients ijk .Use the technique of this section to find the coefficients.Then establish the identity ijk pqr = δp i δq i δr i δp j δq j δr j δp k δq kδr k and use it to show thatijk pqk =δp i δq j −δq i δp j .Use this in turn to prove thata ×(b ×c )=b (a ·c )−c (a ·b )(2.13)for any vectors a ,b ,c .Exercise 2.9.Establish Lagrange’s identity(a ×b )·(c ×d )=(a ·c )(b ·d )−(a ·d )(b ·c ).2.7Norms on the Space of Vectors We often need to characterize the intensity of some vector field locally or globally.For this,the notion of a norm is appropriate.The well-known Euclidean norm of a vector a =a k i k written in a Cartesian frame isa = 3 k =1a 2k1/2.This norm is related to the inner product of two vectors a =a k i k and b =b k i k :we have a ·b =a k b k so thata =(a ·a )1/2.In a non-Cartesian frame,the components of a vector depend on the lengths of the frame vectors and the angles between them.Since the sum of squared components of a vector depends on the frame,we cannot use it to characterize the vector.But the formulas connected with the dot product are invariant under change of frame,so we can use them to characterize the intensity of the vector —its length.Thus for two vectors x =x i e i and y =y j e j written in the arbitrary frame,we can introduce a scalar product (i.e.,a simple dot product)x ·y =x i e i ·y j e j =x i y j g ij =x i y j g ij =x i y i .Note that only in mixed coordinates does this resemble the scalar product in a Cartesian frame.Similarly,the norm of a vector x isx =(x·x)1/2=x i x j g ij1/2=x i x j g ij1/2=x i x i1/2.This dot product and associated norm have all the properties required from objects of this nature in algebra or functional analysis.Indeed,it is neces-sary only to check whether all the axioms of the inner product are satisfied.(i)x·x≥0,and x·x=0if and only if x=0.This property holdsbecause all the quantities involved can be written in a Cartesianframe where it holds trivially.By the same reasoning,we confirmsatisfaction of the property(ii)x·y=y·x.The reader should check that this holds for any representation of the vectors.Finally,(iii)(αx+βy)·z=α(x·z)+β(y·z)whereαandβare arbitrary real numbers and z is a vector.By the general theory then,the expressionx =(x·x)1/2(2.14) satisfies all the axioms of a norm:(i) x ≥0,with x =0if and only if x=0.(ii) αx =|α| x for any realα.(iii) x+y ≤ x + y .In addition we have the Schwarz inequalityx·y ≤ x y ,(2.15) where in the case of nonzero vectors the equality holds if and only if x=λy for some realλ.The set of all three-dimensional vectors constitutes a three-dimensional linear space.A linear space equipped with the norm(2.14)becomes a normed space.In this book,the principal space is R3.Note that we can introduce more than one norm in any normed space,and in practice a variety of norms turn out to be necessary.For example,2 x is also a norm in R3.We can introduce other norms,quite different from the above. One norm can be introduced as follows.Let e k be a basis of R3and letx =x k e k .For p ≥1,we introduce x p =3 k =1|x k |p 1/p.Norm axioms (i)and (ii)obviously hold.Axiom (iii)is a consequence of the classical Minkowski inequality for finite sums.The reader should be aware that this norm is given in a certain basis.If we use it in another basis,the value of the norm of a vector will change in general.An advantage of the norm (2.14)is that it is independent of the basis of the space.Later,when investigating the eigenvalues of a tensor,we will need a space of vectors with complex components.It can be introduced similarly to the space of complex numbers.We start with the space R 3having basis e k ,and introduce multiplication of vectors in R 3by complex numbers.This also yields a linear space,but it is complex and denoted by C 3.An arbitrary vector x in C 3takes the formx =(a k +ib k )e k ,where i is the imaginary unit (i 2=−1).Analogous to the conjugate number is the conjugate vector to x ,defined byx =(a k −ib k )e k .The real and imaginary parts of x are a k e k and b k e k ,respectively.Clearly,a basis in C 3may contain vectors that are not in R 3.As an exercise,the reader should write out the form of the real and imaginary parts of x in such a basis.In C 3,the dot product loses the property that x ·x ≥0.However,we can introduce the inner product of two vectors x and y asx ,y =x ·y .It is easy to see that this inner product has the following properties.Let x ,y ,z be arbitrary vectors of C 3.Then(i)x ·x ≥0,and x ·x =0if and only if x =0.(ii)x ·y =y ·x .(iii)(αx +βy )·z =α(x ·z )+β(y ·z )where αand βare arbitrarycomplex numbers.The reader should verify these properties.Now we can introduce the norm related to the inner product,x = x ,x 1/2,and verify that it satisfies all the axioms of a norm in a complex linear space.As a consequence of the general properties of the inner product, Schwarz’s inequality(2.15)also holds in C3.2.8Closing RemarksWe close by repeating something we said in Chapter1:A vector is an objective entity.In elementary mathematics we learn to think of a vector as an ordered triple of components.There is,of course,no harm in this if we keep in mind a certain Cartesian frame.But if wefix those components then in any other frame the vector is determined uniquely.Absolutely uniquely!So a vector is something objective,but as soon as we specify its components in one frame we canfind them in any other frame by the use of certain rules.We emphasize this because the situation is exactly the same with ten-sors.A tensor is an objective entity,andfixing its components relative to one frame,we determine the tensor uniquely—even though its components relative to other frames will in general be different.2.9Problems2.1Find the dual basis to e i.(a)e1=2i1+i2−i3,e2=2i2+3i3,e3=i1+i3;(b)e1=i1+3i2+2i3,e2=2i1−3i2+2i3,e3=3i1+2i2+3i3;(c)e1=i1+i2,e2=i1−i2,e3=3i3;(d)e1=cosφi1+sinφi2,e2=−sinφi1+cosφi2,e3=i3.2.2Let˜e1=−2i1+3i2+2i3,e1=2i1+i2−i3,˜e2=−2i1+2i2+i3,e2=2i2+3i3,˜e3=−i1+i2+i3,e3=i1+i3.Find the matrix A jof transformation from the basis˜e i to the basis e j.i2.3Let˜e1=i1+2i2,e1=i1−6i3,˜e2=−i2−i3,e2=−3i1−4i2+4i3,˜e3=−i1+2i2−2i3,e3=i1+i2+i3. Find the matrix of transformation of the basis˜e i to e j.2.4Find(a)a jδjk,(b)a i a jδi j,(c)δi i,(d)δijδjk,(e)δijδji,(f)δji δk jδik.2.5Show that ijk ijl=2δlk.2.6Show that ijk ijk=6.2.7Find(a) ijkδjk,(b) ijk mkjδi m,(c) ijkδk mδj n,(d) ijk a i a j,(e) ijk| ijk|,(f) ijk imnδj m.2.8Find(a×b)×c.2.9Show that(a×b)·a=0.2.10Show that a·(b×c)d=(a·d)b×c+(b·d)c×a+(c·d)a×b.2.11Show that(e×a)×e=a if|e|=1and e·a=0.2.12Let e k be a basis of R3,let x=x k e k,and suppose h1,h2,h3arefixed positive numbers.Show that h k|x k|is a norm in R3.。
ICHQSEM指导原则有哪些？马上给您列出来
ICHQSEM指导原则有哪些？马上给您列出来一、总目录类别主要内容ICH指导原则数量Quality Guidelines 质量指导原则化工、医药、质量保证相关指导原则44Safety Guidelines 安全性指导原则实验室动物实验等临床前研究相关指导原则16Efficacy Guidelines有效性指导原则人类临床研究相关指导原则30Multidisciplinary Guidelines多学科指导原则内容交叉涉及以上三个分类，不可单独划入任何一类的指导原则59总数149二、分目录2.1质量(Quality Guidelines)编号英文题目中文译文发布时间Q1 Stability/稳定性Q1A(R2): Stability Testing ofNew Drug Substances andProductsQ1A(R2)：新型原料药和药品的稳定性测试2003.2.6Q1B: Stability Testing:Photostability Testing of NewDrug Substances and ProductsQ1B: 稳定性测试: 新型原料药和药品的光稳定性测试1996.11.6Q1C: Stability Testing for NewDosage FormsQ1C：新剂型的稳定性1996.11.6测试Q1D: Bracketing and MatrixingDesigns for Stability Testingof New Drug Substances andProductsQ1D ：新型原料药和药品稳定性测试的交叉和矩阵设计 2002.2.7Q1E: Evaluation for StabilityDataQ1E ：稳定性数据的评价2003.2.6Q1F: Stabilitiy Guidelines_WHO Q1F ：WHO 稳定性指导原则2009Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证2005.11 Q3A - Q3DImpurities/杂质Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的杂质问题 2006.10.25Q3B(R2): Impurities in New DrugProductsQ3B(R2): 新型药品中的杂质问题2006.6.2Q3C(R6): Impurities Guideline for Residual Solvents Q3C(R6)：杂质：残留溶剂的指导原则2016.10.20Q3D: Guideline for Elemental Impurities Q3D ：元素杂质的指导原则2014.12.16Q4 - Q4BPharmacopoeias/药典 Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B ：ICH 区域所用药典文本的评价和建议2007.11.1Q4B Frequently Asked Questions Q4B ：常见问题与解答2012.4.26Q4B Annex 1 (R1): Residue onIgnition/Sulphated Ash General ChapterQ4B 附录1(R1): 关于灼烧残渣/灰分 常规篇2010.9.27Q4B Annex 2 (R1): Test for Extractable Volume of Parenteral Preparations General Chapter Q4B 附录2(R1): 关于注射剂可提取容量测试2010.9.27常规篇Q4B Annex 3 (R1): Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B 附录3(R1): 关于颗粒污染物测试:不溶性微粒 常规篇2010.9.27Q4B Annex 4A (R1):Microbiological Examination ofNon-SterileProducts: MicrobialEnumeration Tests GeneralChapterQ4B 附录4A(R1):非无菌药品的微生物检查：微生物计数试验 常规篇2010.9.27Q4B Annex 4B (R1):Microbiological Examination ofNon-Sterile Products Tests for Specified Micro-OrganismsGeneral ChapterQ4B 附录4B(R1): 非无菌产品的微生物检查—特定微生物 常规篇 2010.9.27Q4B Annex 4C (R1):Microbiological Examination ofNon-SterileProducts: AcceptanceCriteria for PharmaceuticalPreparations and Substancesfor Pharmaceutical UseGeneral ChapterQ4B 附录4C(R1): 非无菌产品的微生物检查：药物制备以及药物使用物质的接受标准 常规篇2010.9.27Q4B Annex 5 (R1):Disintegration Test General ChapterQ4B 附录5（R1）：崩解试验 常规篇2010.9.27Q4B Annex 6 Uniformity of Dosage Units General Chapter Q4B 附录6: 统一剂量单位常规篇2013.11.13Q4B Annex 7 (R2): Dissolution Test General Chapter Q4B 附录7(R2): 溶出试验 常规篇2010.11.11Q4B Annex 8 (R1): Sterility Test General Chapter Q4B 附录8(R1): 无菌2010.9.27试验 常规篇Q4B Annex 9 (R1): Tablet Friability General Chapter Q4B 附录9(R1): 片剂易碎性 常规篇2010.9.27Q4B Annex 10 (R1):Polyacrylamide GelElectrophoresis GeneralChapterQ4B 附录10(R1): 聚丙烯酰胺凝胶电泳 常规篇2010.9.27Q4B Annex 11: Capillary Electrophoresis General Chapter Q4B 附录11：毛细管电泳 常规篇2010.6.9 Q4B Annex 12: AnalyticalSieving General ChapterQ4B 附录12：分析筛选 常规篇 2010.6.9Q4B Annex 13: Bulk Density andTapped Density of Powders General ChapterQ4B 附录13：粉末的堆密度和振实密度 2012.6.7Q4B Annex 14: BacterialEndotoxins Test GeneralChapterQ4B 附录14：细菌内毒素试验 常规篇2012.10.18Q5A - Q5E Quality of Biotechnological Products/生物技术产品质量 Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R1):人或者动物细胞系来源的生物技术产品的病毒安全性评估 1999.9.23Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5B: 关于重组DNA 来源的蛋白质产品生产所用的细胞中表达构建的分析1995.11.30 Q5C: Stability Testing ofBiotechnological/BiologicalProductsQ5C: 生物技术/生物产品的稳定性试验1995.11.3Q5D:Derivationand Q 5D: 用于生1997.7.16Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological Products 产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of BiotechnologicalBiological Products Subject to Changes in their Manufacturing Process Q5E: 基于不同生产工艺的生物技术产品/生物产品的可比较性2004.11.18 Q6A- Q6BSpecifications/规格 Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6A: 质量规格：新原料药和药品的检验程序和可接收标准：化学物质 1999.10.6 Q6B: Specifications: TestProcedures and AcceptanceCriteria for Biotechnological/Biological ProductsQ6B: 质量规格：生物技术/生物产品的检验程序和可接收标准1999.3.10Q7 GoodManufacturingPractice/GMP Q7: Good ManufacturingPractice Guide for Active Pharmaceutical Ingredients Q7: 原料药GMP 指南 2000.11.1Q7 Questions and Answers Q7 问答部分2015.6.10Q8 Pharmaceutica l Development/药物研发 Q8(R2): Pharmaceutical DevelopmentQ8(R2): 药物研发 2009.8Q8, Q9 and Q10 Questions & Answers (R4) Q8/Q9/Q10问答部分(R4)2010.11.11Q9 Quality RiskManagement/质量风险管理Q9: Quality Risk ManagementQ9: 质量风险管理 2005.11.09Q10 Pharmaceutical Quality System/药物质量体系Q10: Pharmaceutical Quality System Q10: 药物质量体系2008.6.4Q11 Development and Manufacture of Drug Substances/化Q11: Development and Manufacture of Drug Substances (Chemical Entities and Q11：化学药品的研发与生产（化2012.5.1学药品的研发与生产 Biotechnological/BiologicalEntities)学实体以及生物科技/生物制品）Q11：Questions and AnswersQ11：问答部分 2016.10.132.2安全性(Safety Guidelines)编号英文题目 中文译文 发布时间S1A - S1C Carcinogenicity Studies/致癌性研究S1A: Need for Carcinogenicity Studies of Pharmaceuticals S1A: 药物致癌性的研究需求 1995.11.29 S1B: Testing forCarcinogenicity of PharmaceuticalsS1B: 药物致癌性测试1997.7.16S1C(R2): Dose Selectionfor Carcinogenicity Studies of PharmaceuticalsS1C(R2): 药物致癌性研究的剂量选择2008.3.11S2 GenotoxicityStudies/基因毒性研究S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S2(R1): 关于人用药基因毒性试验和数据解读的指导原则2011.11.9S3A - S3BToxicokinetics andPharmacokinetics/毒代动力学和药代动力学S3A: Note for Guidance onToxicokinetics: TheAssessment of Systemic Exposure inToxicity StudiesS3A ：毒理动力学指导原则说明：毒性研究中系统性暴露的评价1994.10.27S3A Implementation Working Group Questions and Answers S3A 实施工作组问答：毒代动力学指导原则说明：毒性研究中的全身暴露量评价集中于微量采样（中文版：征求意见稿）2016.1.19 S3B: Pharmacokinetics Guidance for Repeated Dose S3B ：关于重复剂量组织1994.10.27TissueDistribution Studies分布研究的药代动力学指导原则 S4 ToxicityTesting/毒性试验S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S4：动物慢性毒性试验的持续时间（啮齿动物和非啮齿动物毒性试验）1998.9.2S5 Reproductive Toxicology/生殖毒性 S5(R2):Detection ofToxicity to Reproductionfor Medicinal Products &Toxicity to Male FertilityS5(R2): 检测药品的生殖毒性以及对雄性生殖能力的毒性 2000.11S6 Biotechnological Products/生物技术产品 S6(R1): Preclinical SafetyEvaluation ofBiotechnology-Derived PharmaceuticalsS6(R1): 生物科技来源药品的临床前安全性评价2011.6.12S7A - S7B Pharmacology Studies/药理学研究 S7A: SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS S7A ：人用药的安全性药理学研究 2000.11.8 S7B: The Non-ClinicalEvaluation of thePotential forDelayed Ventricular Repolarization (QTInterval Prolongation) byHuman PharmaceuticalsS7B ：人用药延迟心室复极化（QT 间期延长）潜力的非临床评价2005.5.12S8 Immunotoxicology Studies 免疫毒理学研究 S8: Immunotoxicity Studiesfor Human PharmaceuticalsS8：人用药免疫毒性研究2005.9.15S9 NonclinicalEvaluation forAnticancerPharmaceuticals/抗癌药物的非临床评价S9: Nonclinical Evaluation for Anticancer Pharmaceuticals S9：抗癌药物的非临床评价2009.10.29S9 Implementation Working Group Questions and Answers S9 实施工作组问答部分2016.6.8S10 Photosafety Evaluation/光安全性评价 S10: Photosafety Evaluation of Pharmaceuticals S10：药物的光安全性评价2013.11.132.3有效性(Efficacy Guidelines)编号英文题目中文译文发布时间E1 Clinical Safety for Drugs used in Long-Term Treatment/长期使用的药物的临床安全性 E1: The extent of PopulationExposure to Assess ClinicalSafety for Drugs Intended for Long-term Treatment of Non-life-threateningConditionsE1: 用于评估长期治疗非危及生命性疾病的药物临床安全性的人群暴露程度1994.10.27E2A - E2FPharmacovigilance/药物警戒性E2A: Clinical Safety DataManagement: Definitions and Standards for Expedited ReportingE2A: 临床安全性数据管理：快速报告的定义和标准（中文版：征求意见稿） 1994.10.27E2B(R3):ImplementationGuide for ElectronicTransmission ofIndividual Case SafetyReports (ICSRs) E2B(R3)Data Elements and MessageSpecificationE2B(R3):个例安全报告（ICSR ）电子传输执行指导原则 E2B （R3）数据元素和信息规范元素（中文版：征求意见稿） 2016.11.10 E2B(R3) QA document_v2_1 E2B(R3) 问答文件（中文版：征求意见稿） 2017.6.1E2C(R2): Periodic Benefit-Risk Evaluation Report E2C(R2):定期获益—风险2012.12.17间评估报告E2C(R2) Implementation Working Group Questions & Answers E2C(R2)实施工作组问答部分2014.3.31E2D: Post-Approval SafetyData Management: Definitions and Standards for Expedited ReportingE2D: 上市后安全性数据的管理：快速报告的定义和标准（中文版：征求意见稿） 2003.11.12E2E: Pharmacovigilance Planning E2E:药物警戒规性划2004.11.18E2F: Development Safety Update Report E2F: 研发安全性更新报告 2010.8.17E3 Clinical StudyReports/临床研究报告 E3: Structure and Content of Clinical Study Reports E3: 临床研究报告的结构与内容 1995.11.30E3 Questions & Answers(R1) ： Structure and Content of Clinical Study ReportsE3 实施工作组 问答部分2012.7.6E4 Dose-Response Studies/剂量反应研究 E4: Dose-Response Information to Support Drug Registration E4: 用于支持药物注册的剂量反应信息 1994.3.10E5 Ethnic Factors/种族因素E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data E5(R1):国外临床数据可接受性的种族因素1998.2.5E5 Implementation WorkingGroup Questions & Answers(R1)E5 实施工作组 问答部分（R1）2006.6.2间E6 GCP/药物临床试验管理规范 E6(R1): Guideline for Good Clinical Practice E6(R1):药物临床试验管理规范指导原则 1996.6.10E6(R2):Integrated Addendum to Good Clinical Practice (GCP) E6(R2):药物临床试验管理规范综合附录2016.11.9E7 Clinical Trials inGeriatric Population/老人中开展的临床试验E7: Studies in Support of Special Populations: GeriatricsE7: 特殊人群的支持性研究：老人病学 1993.6.24E7 Questions & AnswersE7 问答部分 2010.7.6E8 GeneralConsiderations for Clinical Trials/临床试验的一般性考虑 E8: General Considerations for Clinical Trials E8: 临床试验的一般性考虑1997.7.17E9 StatisticalPrinciples for Clinical Trials/临床试验的统计原则E9: Statistical Principles for Clinical Trials E9: 临床试验的统计原则1998.2.5E10 Choice of Control Group in Clinical Trials/试验中对照组的选择 E10: Choice of Control Group and Related Issues in Clinical Trials E10: 临床试验中对照组的选择以及相关问题2000.7.20E11 Clinical Trials inPediatric Population/儿童人群临床研究 E11: Clinical Investigation of Medicinal Products in the Pediatric Population E11：儿科人群药物临床试验 2000.7.20E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population E11(R1): 儿科人群药物临床试验补充2017.8.18 E12 Clinical Evaluation by Therapeutic Category/根据治疗类别进行临床评价 E12: Principles for Clinical Evaluation of New Antihypertensive Drugs E12: 新型抗高血压药物的临床评价原则2000.3.2间E14 Clinical Evaluationof QT/QT 临床评价E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14:非抗心律失常药物QT/QTc 间期延长及致心律失常潜力的临床评价2005.5.12E14 Implementation Working Group Questions & Answers (R3) E14 实施工作组 问答部分（R3）2015.12.10 E15 Definitions in Pharmacogenetics/Pharmac ogenomics/药物基因组学以及遗传药理学相关定义 E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmac ogenetics, Genomic Data and Sample Coding Categories E15: 基因组生物标志物、药物基因组学、遗传药理学、基因组数据以及样本编码分类的定义2007.11.1 E16 Qualification of Genomic Biomarkers/基因组生物标志物的合格条件 E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions E16:与药物或生物制品研发相关的生物标志物：资质提交材料的背景、结构以及格式2010.8.20 E17 Multi-Regional Clinical Trials/多地区临床试验 E17: General principle on planning and Designing Multi-Regional Clinical Trials E17:计划和设计多地区临床试验的一般性原则2016.5.6 E18 Genomic Sampling/基因组取样 E18: Genomic Sampling and Management of Genomic Data E18：基因组采样和基因组数据管理指导原则(中2015.12.10间文版：征求意见稿)2.4多学科(MultidisciplinaryGuidelines)编号 英文题目中文译文 发布时间M1 MedDRA Terminology 监管活动医学词典 MedDRA Data Retrieval and Presentation: Points to Consider MedDRA 数据检索与呈现： 考虑要点（中文版：征求意见稿） 2017.9.1 MedDRA Term Selection: Points to Consider MedDRA 术语选择： 考虑要点（中文版：征求意见稿）2017.9.1 M2 Electronic Standards 电子标准 ICH M2 EWG Work Plan M2专家工作组工作计划2017.3.27 M2: ElectronicStandards for the Transfer of Regulatory Information Final Concept PaperM2监管信息转移的电子标准终版概念文件1994.10.27 ElectronicTransmission of Individual Case Safety Reports Message Specification个例病例安全性报告的电子传输信息规范 2000.11.9 ICH M2 EWG The eCTDBackbone File Specification for Study Tagging FileseCTD 研究标签文件主文件规范2008.6.3 Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) General Recommendation -Procedure监管信息转移的电子标准一般性建议—程序 2015.6.11 Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation – ESTRI 监管信息转移的电子标准一般性建议—ESTRI 网关 2015.6.11Gateway Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF监管信息转移的电子标准文件格式建议—PDF2011.4.5Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML监管信息转移的电子标准文件格式建议—XML2005.11.10 Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF/A监管信息转移的电子标准文件格式建议—PDF/A2014.6.2Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – DOCX监管信息转移的电子标准文件格式建议—DOCX2015.6.11Electronic Standardsfor the Transfer ofRegulatory Information (ESTRI) Controlled Vocabularies Recommendation -Genericode监管信息转移的电子标准控制词汇建议—代码2015.6.11Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) Information Transfer Recommendation – EDIINT AS1/AS2监管信息转移的电子标准信息转移建议—EDIINT AS1/AS22010.6.10Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Integrity – MD5监管信息转移的电子标准文件完整性—MD52010.6.10Electronic Standards for the Transfer of 监管信息转移的电子标准文件完2015.6.11Regulatory Informaation (ESTRI) File IntegrityRecommendation - SHA-256整性建议—SHA-256M2 Glossary of Terms and Abbreviations M2术语和简写词汇表2015.6.11 ICH M2 File Format Criteria M2文件格式标准 2014.11.10Use of OIDs & UUIDs in ICH Messages OIDs & UUIDs 在ICH 信息中的使用2015.6.11 M3 Nonclinical Safety Studies 非临床研究 M3(R2) Questions and Answers (R2)M3(R2)问答 (R2) 2012.3.5 M3(R2): Guidance onNonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsM3(R2):关于实施药物人体临床试验以及上市批准非临床安全性研究的指导原则2009.6.11M4 : The Common Technical Document 通用技术文件 M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human UseM4（R4）：人用药物注册通用技术文档的组织（中文版：征求意见稿） 2016.6.15 M4 Implementation Working Group Questions & Answers (R3) M4执行工作组问答（R3）（中文版：征求意见稿） 2004.6.10 The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1)M4Q （R1）：人用药物注册通用技术文档：药学部分（中文版：征求意见稿） 2002.9.12 M4Q Implementation Working Group Questions & Answers (R1) M4Q 执行工作组问答（R1）（中文版：征求意见稿）2003.7.17 The Common Technical Document for the M4S （R2）：人用药物注册通用技2002.12.2Registration of Pharmaceuticals for Human Use: Safety – M4S(R2)术文档：安全性部分（中文版：征求意见稿）M4S Implementation Working Group Questions & Answers (R4) M4S 执行工作组问答 （R4）（中文版：征求意见稿）2003.11.11 Efficacy- M4E(R2) M4E （R2）：人用药物注册通用技术文档：有效性部分（中文版：征求意见稿）2016.6.15M4E Implementation Working Group Questions & Answers (R4) M4E 执行工作组问答（R4）（中文版：征求意见稿）2004.6.10 M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准 The Re-development ofthe Standard forE2B(R3) and the Development of Standards for the Identification of Medicinal Products(IDMP)(ICH M5)ICH M5:E2B(R3)标准的再制定及医药产品鉴定标准的制定2010.11.1 ICH E2B(R3)Implementation Working Group ICH E2B(R3) Guideline: Electroni c Transmission of Individual Case Safety Reports (ICSRs) E2B(R3)实施工作组个例病例安全报告的电子传输问答部分 2016.11.10 Appendix I (B) to theImplementation Guide for Electronic Transmission of Individual Case SafetyReports (ICSRs)个例病例安全报告的电子传输实施指南附录 I (B) 2016.11.10 Appendix I (G) to theImplementation Guide for Electronic Transmission of Individual Case Safety个例病例安全报告的电子传输实施指南附录 I (G)2016.11.10Reports (ICSRs) Implementation Guidefor Electronic Transmission of Individual Case Safety Reports(ICSRs)个例病例安全报告的电子传输实施指南 2016.11.10 M6 Gene Therapy 基因治疗 Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionM6: 病毒和基因治疗载体的脱落和传播终版概念文件 2009.8.26 General Principles to Address Virus and Vector Shedding 解决病毒和基因治疗载体脱落的基本原则 2009.6An inventory of shedding data from clinical gene therapy trials临床基因疗法试验脱落数据目录2007.7.30 Final Business Plan M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionM6: 病毒和基因治疗载体的脱落和传播终版业务计划 2009.8.27 M7 Genotoxic Impurities 遗传毒性杂质 M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7：评估和控制药物中的DNA 活性（致突变）杂质以限制潜在的致癌风险 2014.6.23 M7(R1): Addendum to M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskM7(R1)： 评估和控制药物中 DNA 反应性（致突变）杂质以限制潜在的致癌风险（中文版：征求意见稿） 2017.3.31 M8 Electronic Common Technical Document (eCTD) 电子通用技术文件 Electronic Common Technical Document Specification V3.2.2电子通用技术文件规范 V3.2.2 2008.7.16 M8 : Electronic Common M 8: 电子通用2015.12.9Technical Document Concept Paper 技术文件概念文件ICH M8 EWG/IWG Work Plan M8: 电子通用技术文件工作计划2017.3.13 Support Documentation for M8: eCTD EWG eCTD v4.0 Implementation Package v1.2 M8：eCTD 专家工作组eCTD v4.0实施包 v1.2 支持性证明文件2016.11 Orientation Material forM8: eCTD EWG eCTD v4.0 Implementation Package v1.2 M8：eCTD 专家工作组eCTD v4.0实施包 v1.2 培训材料2016.11 ICH Electronic CommonTechnical Document (eCTD) v4.0 Implementation Guidev1.2ICH eCTD v4.0 实施指南 v1.2 2016.11.10 eCTD v4.0 Implementation Package v1.2eCTD v4.0 实施包 v1.2 USFDA eCTD v4.0 Implementation Package History v1.1 美国FDA eCTDv4.0 实施包历史 v1.1USFDA Module 1Electronic Common Technical Document (eCTD) v4.0 ImplementationGuide v1.1美国FDA 模块1 eCTD v4.0 实施指南 v1.1 2017.2.20 ICH eCTD v4.0 Requirements ICH eCTD v4.0 要求ICH M8 Expert WorkingGroup Specification for Submission Formats for eCTDeCTD 提交格式规范 2016.11.1Change Control Process for the eCTD eCTD 变更控制过程2017.4 Request for change 请求变更表M9 Biopharmaceutic s Classification System-based M9: Biopharmaceutics Classification System-based Biowaivers Final M9：基于生物药剂学分类系统的生物豁免业务计2016.10.7Biowaivers 基于生物药剂学分类系统的生物豁免 endorsed Business Plan划ICH M9 EWG Work Plan M9 专家工作组工作计划2017.2.9 M9: Biopharmaceutics Classification System-based Biowaivers Final endorsed Concept PaperM9：基于生物药剂学分类系统的生物豁免概念文件 2016.10.7 M10 Bioanalytical Method Validation 生物样品分析的方法验证 M10: Bioanalytical Method Validation Final endorsed Business Plan M10: 生物样品分析的方法验证业务计划 2016.10.7ICH M10 EWG Work Plan M10: 专家工作组工作计划 2017.3.10 M10: Bioanalytical Method Validation Final endorsed Concept Paper M10: 生物样品分析的方法验证概念文件2016.10.7文章来源：龙腾整理。
USP 通用章节目录
USP29-通用章节指导目录(附录)Guide to General Chapters 通用章节指导目录中此颜色并且带有“***”的为新增内容。
General Requirements for Test and Assays检查与含量分析的一般要求＜1＞INJECTIONS……2455注射剂＜11＞USP REFERENCE STANDARDS……2458USP对照品Apparatus for Test and Assays用于检查与含量分析的器具＜16＞AUTOMATED METHODS OF ANAL YSIS……2491自动化分析方法＜21＞THERMOMETERS……2497温度计＜31＞VOLUMETRIC APPARATUS……2497容量器具＜41＞WEIGHTS AND BALANCES……2499砝码与天平Microbiological Tests 微生物检查法＜51＞ANTIMICROBIAL EFFECTIVENESS TESTING……2499抗菌剂有效性检查法＜55＞BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS (2501)生物指示剂－耐药性实验＜61＞MICROBIAL LIMIT TESTS……2503微生物限度检查法＜71＞STERILITY TESTS……2508无菌检查法Biological tests and assays生物检查法与测定法＜81＞ANTIBIOTICS—MICROBIAL ASSAYS……2513抗生素－微生物测定＜85＞BACTERIAL ENDOTOXINS TEST……2521细菌内毒素检查法＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525体外的生物反应性检查法＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO……2526体内的生物反应性检查法＜91＞CALCIUM PANTOTHENATE ASSAY……2530泛酸钙测定法＜111＞DESIGN AND ANAL YSIS OF BIOLOGICAL ASSAYS……2531 生物测定法的设计与分析＜115＞DEXPANTHENOL ASSAY……2543右泛醇（拟胆碱药）测定法＜121＞INSULIN ASSAYS……2544胰岛素测定法＜141＞PROTEIN—BIOLOGICAL ADEQUACY TEST……2546蛋白质－生物适应性试验＜151＞PYROGEN TEST……2546热原检查法＜161＞TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES (2547)输血输液用具以及相类似的医疗器械＜171＞VITAMIN B12 ACTIVITY ASSAY……2548维生素B12活性测定法Chemical Tests and assays化学实验与测定法＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES (2549)鉴别－有机氮碱？＜191＞IDENTIFICATION TESTS—GENERAL……2550鉴别实验－通用＜193＞IDENTIFICATION—TETRACYCLINES……2551鉴别－四环素＜197＞SPECTROPHOTOMETRIC IDENTIFICATION TESTS......2552分光光度计鉴别实验＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST.. (2553)薄层色谱鉴别实验Limit Test 限度检查法＜206＞ALUMINUM……2554铝＜211＞ARSENIC……2554砷＜221＞CHLORIDE AND SULFATE……2555氯和硫＜223＞DIMETHYLANILINE……2555二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE……25564－？－四环素＜231＞HEA VY METALS……2556重金属＜241＞IRON……2557铁＜251＞LEAD……2558铅＜261＞MERCURY……2558汞＜271＞READIL Y CARBONIZABLE SUBSTANCES TEST……2560易碳化物检查法＜281＞RESIDUE ON IGNITION……2560灼烧残渣＜291＞SELENIUM……2560硒Other Tests and Assays 其它检查法与测定法＜301＞ACID-NEUTRALIZING CAPACITY……2561酸中和容量＜311＞ALGINATES ASSAY……2562藻酸盐测定法＜331＞AMPHETAMINE ASSAY……2562苯丙胺测定法<341> ANTIMICROBIAL AGENTS—CONTENT……2563 抗菌剂－含量<345> Assay for Citric Acid/Citrate and Phosphate……2565 柠檬酸/柠檬酸盐和磷酸盐的测定＜351＞ASSAY FOR STEROIDS……2565类固醇（甾类化合物）测定法＜361> BARBITURATE ASSAY……2565 巴比妥类药物测定法＜371＞COBALAMIN RADIOTRACER ASSAY……2566钴铵素放射性跟踪剂测定法＜381＞ELASTOMERIC CLOSURES FOR INJECTIONS……2567 注射剂的弹性密封件＜391＞EPINEPHRINE ASSAY……2567肾上腺测定法＜401＞FATS AND FIXED OILS……2568脂肪与混合油＜411＞FOLIC ACID ASSAY……2571叶酸测定法＜425＞IODOMETRIC ASSAY—ANTIBIOTICS……2572碘量检查法－抗生素＜429＞LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE (2572)粒子尺寸的光衍射测量＜431＞METHOXY DETERMINA TION……2575甲氧基测定法＜441＞NIACIN OR NIACINAMIDE ASSAY……2576烟酰或烟酰胺测定法＜451＞NITRITE TITRATION……2578亚硝酸盐滴定＜461＞NITROGEN DETERMINA TION……2578氮测定法＜466＞ORDINARY IMPURITIES……2579一般杂质＜467＞ORGANIC VOLATILE IMPURITIES……2580有机的易挥发杂质＜471＞OXYGEN FLASK COMBUSTION……2590氧瓶燃烧法＜481＞RIBOFLAVIN ASSAY……2590核黄素测定法＜501＞SALTS OF ORGANIC NITROGENOUS BASES……2591有机氮盐＜511＞SINGLE-STEROID ASSAY……2591单一的类固醇测定法＜521＞SULFONAMIDES……2592磺胺制剂＜531＞THIAMINE ASSAY……2593硫胺素测定法＜541＞TITRIMETRY……2593滴定法＜551＞ALPHA TOCOPHEROL ASSAY……2596α－维生素E测定法＜561＞ARTICLES OF BOTANICAL ORIGIN……2596植物起源的药品＜563＞IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN……2603植物药品的鉴别＜565＞BOTANICAL EXTRACTS……2609植物提取＜571＞VITAMIN A ASSAY……2611维生素A的测定法＜581＞VITAMIN D ASSAY……2612维生素D的测定法＜591＞ZINC DETERMINATION……2616锌的测定法Physical Test and Determinations物理检查与测定法INHALERS, AND DRY POWDER ＜601＞AEROSOLS, NASAL SPRAYS,USP28METERED-DOSEINHALERS……2617气溶胶，鼻用喷雾剂，定量吸入器与干粉吸入器＜611＞ALCOHOL DETERMINATION……2637乙醇测定法＜616＞BULK DENSITY AND TAPPED DENSITY……2638堆密度与拍实密度＜621＞CHROMATOGRAPHY…….2639色谱法＜631＞COLOR AND ACHROMICITY……2651呈色与消色＜641＞COMPLETENESS OF SOLUTION……2652完全溶解＜643＞TOTAL ORGANIC CARBON……2652总有机碳＜645＞WA TER CONDUCTIVITY……2653水电导率＜651＞CONGEALING TEMPERA TURE……2654凝点温度＜661＞CONTAINERS……2655容器＜671＞CONTAINERS—PERMEATION……2663容器－渗透＜691＞COTTON……2664棉花＜695＞CRYSTALLINITY……2665结晶性＜696＞Crystallinity Determination By Solution Calorimetry……2666 通过溶液量热学测定结晶性＜698＞DELIVERABLE VOLUME……2667可转移的体积＜699＞DENSITY OF SOLIDS……2669固体密度＜701＞DISINTEGRATION……2670崩解时限***＜701＞Disintegration (Harmonized Chapter, Official April 1,2006)………..2671崩解时限（协调的章节，法定日期，2006.4.1）＜711＞DISSOLUTION……2673 溶出度***＜711＞Dissolution (Harmonized Chapter, Official April 1,2006)………..2675 溶出度（协调的章节，法定日期，2006.4.1）＜721＞DISTILLING RANGE……2682馏程＜724＞DRUG RELEASE……2682药物释放度***＜724＞Drug releasee (Harmonized Chapter, Official April 1,2006)………..2690药物释放度（协调的章节，法定日期，2006.4.1）＜726＞ELECTROPHORESIS……2694电泳＜727＞CAPILLARY ELECTROPHORESIS……2696毛细管电泳法***＜730＞Plasma Spectrochemistry….2700 血浆光谱化学＜731＞LOSS ON DRYING……2704干燥失重＜733＞LOSS ON IGNITION……2704灼烧失重＜736＞MASS SPECTROMETRY……2705 质谱＜741＞MELTING RANGE OR TEMPERATURE……2708熔距或熔点＜751＞METAL PARTICLES IN OPHTHALMIC OINTMENTS……2709眼用软膏中的金属粒子＜755＞MINIMUM FILL……2710最低装填量＜761＞NUCLEAR MAGNETIC RESONANCE……2710核磁共振＜771＞OPHTHALMIC OINTMENTS……2715眼用软膏＜776＞OPTICAL MICROSCOPY……2716光学显微镜＜781＞OPTICAL ROTATION……2718旋光＜785＞OSMOLALITY AND OSMOLARITY……2718同渗重摩与同渗容摩＜786＞PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANAL YTICAL SIEVING (2720)通过筛分法估算粒子分布＜788＞PARTICULATE MATTER IN INJECTIONS……2722注射剂中的颗粒＜789＞PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS……2729眼用溶液中的颗粒＜791＞pH (2730)＜795＞PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS (2731)药物混合－非无菌制剂＜797＞PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS (2735)药物混合－无菌制剂＜801＞POLAROGRAPHY……2752极谱法＜811＞POWDER FINENESS……2754粉剂细度＜821＞RADIOACTIVITY……2755放射性＜823＞RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY —COMPOUNDING……2763用于正电子发射断层摄影术的放射性药物＜831＞REFRACTIVE INDEX……2766折光率＜841＞SPECIFIC GRA VITY……2766比重＜846＞SPECIFIC SURFACE AREA……2767 比表面积＜851＞SPECTROPHOTOMETRY AND LIGHT-SCA TTERING……2770分光光度计与光散射＜861＞SUTURES—DIAMETER…2775缝线－直径＜871＞SUTURES—NEEDLE ATTACHMENT……2775缝线－穿孔实验＜881＞TENSILE STRENGTH…..2776张力＜891＞THERMAL ANAL YSIS……2776热分析＜905＞UNIFORMITY OF DOSAGE UNITS……2778制剂单位的含量均匀度＜905＞UNIFORMITY OF DOSAGE UNITS (Harmonized Chapter, Official April 1,2006)……2780制剂单位的含量均匀度（协调的章节2006.4.1）＜911＞VISCOSITY……2785粘度＜921＞WA TER DETERMINA TION……2785水测定法＜941＞X-RAY DIFFRACTION……2788X光衍射General Information通用信息＜1010＞ANAL YTICAL DATA—INTERPRETA TION AND TREATMENT (2790)分析数据－解释与处理＜1015＞AUTOMA TED RADIOCHEMICAL SYNTHESIS APPARATUS (2801)放射性自动合成装置＜1031＞THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS (2802)用于药物容器、医疗设施和植入剂的材料的生物相容性＜1035＞BIOLOGICAL INDICATORS FOR STERILIZATION……2811灭菌用生物指示剂＜1041＞BIOLOGICS……2814生物制剂***＜1043＞Ancillary Material for Cell, Gene, and Tissue-Engineered Products…….2814 细胞，基因与组织设计产品的辅助材料＜1045＞BIOTECHNOLOGY-DERIVED ARTICLES……2821生物技术提取产品＜1046＞CELL AND GENE THERAPY PRODUCTS……2831细胞与基因治疗产品＜1047＞BIOTECHNOLOGY-DERIVED ARTICLES—TESTS……2858生物技术产品－检查法＜1048＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANAL YSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS1 (2883)生物产品质量：从蛋白质产品中提取的r-DNA产品在细胞中表达结构的分析＜1049＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS1 (2884)生物技术产品的质量：生物技术/生物产品的稳定性实验＜1050＞VIRAL SAFETY EV ALUA TION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN (2887)从人或动物细胞中提取的生物技术产品的病毒安全性评估＜1051＞CLEANING GLASS APPARATUS……2896玻璃容器的清洗＜1061＞COLOR—INSTRUMENTAL MEASUREMENT……2896显色－仪器测量***＜1065＞Ion Chromatography………2898 离子色谱法＜1074＞EXCIPIENT BIOLOGICAL SAFETY EV ALUA TION GUIDELINES (2900)赋形剂（辅料）生物安全性评估指导＜1075＞GOOD COMPOUNDING PRACTICES……2903好的混合操作＜1078＞GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS (2906)批药品赋形剂的生产管理规范***＜1079＞Good Storage and Shipping Practices……2915 良好的贮存与船运规范＜1081＞GEL STRENGTH OF GELATIN……2920白凝胶的凝胶强度＜1086＞IMPURITIES IN OFFICIAL ARTICLES……2920药典物品中的杂质＜1087＞INTRINSIC DISSOLUTION……2923内部的溶出度＜1088＞IN VITRO AND IN VIVO EV ALUA TION OF DOSAGE FORMS (2924)体内与体外的剂型的评估＜1090＞IN VIVO BIOEQUIV ALENCE GUIDANCES……29291体内生物等效性指导＜1091＞LABELING OF INACTIVE INGREDIENTS……2968非活性成分的标示＜1101＞MEDICINE DROPPER……2969医用滴管＜1111＞MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS (2969)非无菌药品中的微生物分布＜1116＞MICROBIOLOGICAL EV ALUA TION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS……2969洁净的房间与其它可控环境的微生物评估＜1118＞MONITORING DEVICES—TIME, TEMPERATURE, AND HUMIDITY (2976)监控装置－时间、温度与湿度＜1119＞NEAR-INFRARED SPECTROPHOTOMETRY……2979近红外分光光度测定法***＜1120＞Raman Spectrophotometry……..2983 Raman分光光度测定法＜1121＞NOMENCLATURE……2988命名***＜1136＞Packaging－Unit-of-Use……2989包装－单元使用＜1146＞PACKAGING PRACTICE—REPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE CONTAINER……2990 包装操作－将单一固体口服药品产品再包装成单元剂量＜1150＞PHARMACEUTICAL STABILITY……2994药物稳定性＜1151＞PHARMACEUTICAL DOSAGE FORMS……2996药物剂型＜1160＞PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING (3006)按处方混合的药物的计算＜1171＞PHASE-SOLUBILITY ANAL YSIS……3016相溶解分析***＜1174＞Powder Flow….3017 粉末流动性＜1176＞PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS….3020 处方天平与容量器具***＜1177＞Good Packaging Practices….3021 良好的包装操作***＜1178＞Good Repackaging Practices….3023 良好的再包装操作＜1181＞SCANNING ELECTRON MICROSCOPY……3025扫描电子显微镜＜1191＞STABILITY CONSIDERATIONS IN DISPENSING PRACTICE……3029 分装操作中稳定性考察＜1196＞PHARMACOPEIAL HARMONIZATION……3031药典的一致性＜1207＞STERILE PRODUCT PACKAGING—INTEGRITY EV ALUATION (3035)无菌产品包装－完整性评估＜1208＞STERILITY TESTING—V ALIDATION OF ISOLATOR SYSTEMS (3037)无菌实验－隔离系统的验证＜1209＞STERILIZATION—CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS……3040灭菌－化学与物理化学的指示剂以及二者的综合＜1211＞STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES (3041)药典物品中的灭菌与灭菌保证＜1216＞TABLET FRIABILITY……3046片剂的脆碎度＜1221＞TEASPOON……3047茶匙＜1222＞TERMINALL Y STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE……3047最终灭菌产品－放行参数＜1225＞V ALIDATION OF COMPENDIAL METHODS……3050药典方法的验证＜1227＞V ALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES (3053)从药物中回收微生物的验证＜1230＞W ATER FOR HEALTH APPLICATIONS……3055健康用水＜1231＞W ATER FOR PHARMACEUTICAL PURPOSES……3056制药用水＜1241＞W ATER–SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS (3074)在药物系统中水与固体的相互作用＜1251＞WEIGHING ON AN ANAL YTICAL BALANCE……3076关于分析天平的称重***＜1265＞Written Prescription Drug Information－Guidelines……….3078 书面的处方药信息－指南Dietary Supplements营养补充剂General Tests and Assays 一般检查法与测定法＜2021＞MICROBIAL ENUMERATION TESTS—NUTRITIONAL AND DIETARY SUPPLEMENTS (3080)微生物数量实验－营养与食品添加剂＜2022＞MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS (3083)不得检出特定微生物的程序－营养与营养补充剂＜2023>MICROBIOLOGICAL A TTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS……3087非无菌的营养与食品添加剂中的微生物分布<2040>DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS (3089)食品添加剂的崩解与溶出<2091>WEIGHT VARIATION OF DIETARY SUPPLEMENTS……3092食品添加剂的重量差异<2750>MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS (3093)食品添加剂的生产操作。
ICH-指导原则文件目录
ICH 的论题主要分为四类，因此ICH 根据论题的类别不同而进行相应的编码分类：1.“Q”类论题：Q 代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。
Q1/Q2...Q10 都属于这种。
2.“S”类论题：S 代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。
3.“E”类论题：E 代表EFFICACY ，指那些与人类临床研究相关的课题。
4.“M”类论题：M 代表MULTIDISCIPLINARY，指那些不可单独划入以上三个分类的交叉涉及的论题。
1. Q1A(R2): Stability Testing of New Drug Substances and Products新原料药和制剂的稳定性试验2. Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验3. Q1C: Stability Testing for New Dosage Forms新剂型的稳定性试验4. Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and DrugProducts原料药和制剂稳定性试验的交叉和矩阵设计5. Q1E: Evaluation of Stability Data稳定性数据的评估6. Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III 和IV，药物注册申请所提供的稳定性数据7. Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论8. Q3A(R2): Impurities in New Drug Substances新原料药中的杂质9. Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质10. Q3C(R5): Impurities: Guideline for Residual Solvents杂质：残留溶剂指南11. Q3C(R6): Impurities: Guideline for Residual SolventsPDE for Triethylamine and PDE for Methylisobutylketone杂质：残留溶剂指南三乙胺的日允许接触剂量及甲基异丁基酮的日允许接触剂量12. Q3D: Guideline for Elemental impurities主要杂质指南13. Q4A: Pharmacopoeial Harmonisation 药典的协调14. Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH RegionsICH 地区使用的药典正文评估和建议15. Q4B Annex1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Residue on Ignition/Sulphated Ash General Chapter附录1 ICH 地区使用的药典正文评估和建议灼烧残渣/灰分通则16. Q4B Annex2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter附录2 ICH 地区使用的药典正文评估和建议注射剂可提取体积测试通则17. Q4B Annex3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter 附录3 地区使用的药典正文评估和建议颗粒污染物测试:不溶性微粒通则18. Q4B ANNEX 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Microbial Enumerations Tests General Chapter附录4A(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:微生物计数法通则19. Q4B ANNEX 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Test for Specified Micro-organisms General Chapter附录4B(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:控制菌检查法通则20. Q4B ANNEX 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Acceptance Criteria For Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter附录4C(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:药物制剂及原料药的认可标准通则21. Q4B ANNEX 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Disintegration Test General Chapter附录5(R1) ICH 地区使用的药典正文评估和建议崩解试验通则22. Q4B ANNEX 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Uniformity of dosage units General Chapter附录6 ICH 地区使用的药典正文评估和建议含量均匀度通则word 格式-可编辑-感谢下载支持23. Q4B ANNEX 7(R2) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Dissolution Test General Chapter附录7(R2) ICH 地区使用的药典正文评估和建议溶解度测试通则24. Q4B ANNEX 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Sterility Test General Chapter附录8(R1) ICH 地区使用的药典正文评估和建议无菌检查通则25. Q4B ANNEX 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Tablet Friability General Chapter附录9(R1) ICH 地区使用的药典正文评估和建议片剂脆碎度检查通则26. Q4B ANNEX 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter附录10(R1) ICH 地区使用的药典正文评估和建议聚丙烯酰胺凝胶电泳通则27. Q4B ANNEX 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Capillary Electrophoresis General Chapter附录11 ICH 地区使用的药典正文评估和建议毛细管电泳通则28. Q4B ANNEX 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Analytical Sieving General Chapter附录12 ICH 地区使用的药典正文评估和建议分析筛选通则29. Q4B ANNEX 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Bulk Density and Tapped Density of Powders General Chapter附录13 ICH 地区使用的药典正文评估和建议粉末的松密度与密切度30. Q4B ANNEX 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Bacterial Endotoxins Test General Chapter附录14 ICH 地区使用的药典正文评估和建议细菌内毒素检测通则31. Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines ofHuman or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估32. Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in CellsUsed for Production of r-DNA Derived Protein Products生物技术产品的质量：rDNA 衍生蛋白质产品生产细胞的表达构建体分析33. Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/BiologicalProducts生物技术产品的质量：生物技术产品/生物制品的稳定性试验34. Q5D: Derivation and Characterization of Cell Substrates Used for Production ofBiotechnological/Biological Products用于生产生物技术产品/生物制品的细胞基质的来源和鉴定35. Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in TheirManufacturing Process生产工艺变更后生物技术产品/生物制品的可比性质量标准36. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances andNew Drug Products: Chemical Substances (including decision trees)规范：新原料药和新制剂的检测方法和可接收标准：化学物质(包括决定过程)37. Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/BiologicalProducts规范：生物技术产品/生物制品的检验方法和可接收标准38. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients药物活性成份的GMP 指南39. Q8(R2): Pharmaceutical Development药物开辟40. Q9: Quality Risk Management质量风险管理41. Q10: Pharmaceutical Quality System药物质量体系42. Q11:Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities)原料药的开辟与创造(化学实体与生物技术/生物制品实体)1. S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌试验的必要性2. S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌试验3. S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌试验的剂量选择4. S2(R1) : Guidance on Genotoxicity Testing and Data Interpretation for PharmaceuticalsIntended for Human Use人用药物的遗传毒性试验和数据分析指导原则5. S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in ToxicityStudies毒物代谢动力学指南的注释：毒性研究中全身暴露的评价6. S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学：重复给药的组织分布研究指导原则7. S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent ToxicityTesting)动物体内慢性毒性持续时间的检验(啮齿类和非啮齿类毒性试验)8. S5(R2) : Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to MaleFertility药品的繁殖毒性检测及雄性生育力毒性9. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术药品的临床前安全性试验10. S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药物的安全性药理研究11. S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QTInterval Prolongation) by Human Pharmaceuticals 人用药延迟心室复极化(QT 间期延长) 潜在作用的非临床评价指导原则12. S8: Immunotoxicity Studies for Human Pharmaceuticals人用药品的免疫毒理学研究13. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物的临床前评价14. S10: Photosafety Evaluation of Pharmaceuticals药物的光安全评价1. E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended forLong-Term Treatment of Non-Life-Threatening Conditions对非危及生命的疾病的长期治疗药物进行临床安全性评估的人群暴露程度2. E2A: Definitions and Standards for Expedited Reporting快速报告的定义和标准3. E2C(R2): Periodic Benefit-Risk Evaluation Report上市药品定期风险效益评估报告4. E2D: Post-Approval Safety Data Management: Definitions and Standards for ExpeditedReporting 批准后安全性数据管理：快速报告的定义和标准5. E2E: Pharmacovigilance Planning 药物警戒计划6. E2F: Development Safety Update Report 安全性更新报告7. E3: Structure and Content of Clinical Study Reports临床研究报告的结构与内容8. E4: Dose-Response Information to Support Drug Registration新药注册所需量-效关系的资料9. E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data对国外临床研究资料的种族因素的可接受性10. E6(R1): Good Clinical Practice: Consolidated Guideline药品临床研究规范(GCP)一致性指导原则11. E6(R2): Integrated Addendum to ich E6(R1): Guideline for Good Clinical Practice E6(R1)整合的附录：药品临床研究规范指南12. E7: Studies in Support of Special Populations: Geriatrics老年人群的临床研究13. E8: General Considerations for Clinical Trials临床研究总则14. E9: Statistical Principles for Clinical Trials临床研究统计原则15. E10: Choice of Control Group and Related Issues in Clinical Trials临床研究对照组的选择及相关问题16. E11: Clinical Investigation of Medicinal Products in the Pediatric Population儿童人群的临床研究17. E12: Principles for Clinical Evaluation of New Antihypertensive Drugs抗高血压新药的临床评价指导原则18. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and ProarrhythmicPotential for Non-Antiarrhythmic Drugs非抗心律失常药物致QT/QTc 间期延长及潜在心律失常作用的临床评价19. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, GenomicData and Sample Coding Categories基因组生物标记物、药物基因组学、遗传药理学、基因组数据和样本编码分类的定义20. E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structureand Format of Qualification Submissions与药物或者生物技术产品相关的生物标记物研发: 申请资料的内容、结构和格式21. E17: General principle on planning/designing Multi-Regional Clinical Trials规划多地区临床试验的普通原则22. E18: Guideline on Genomic Sampling and Management of Genomic Data基因组数据采集与管理的指导原则1. M3: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals药物进行人体临床试验和上市许可申请的临床前安全性研究指导原则2. M4(R3): Organisation of the Common Technical Document for the Registration ofPharmaceuticals for Human Use人用药物注册申请的通用技术文件组织结构3. M4E(R1): The Common Technical Document for Registration of Pharmaceuticals for HumanUse Clinical人用药物注册申请的通用技术文件：临床4. M4E(R2): Revision of M4E Guideline on Enhancing Format and Structure of Benefit-riskInformation in ICH EfficacyM4E 指南修订，优化临床研究风险评估的格式与结构5. M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Quality人用药物注册申请的通用技术文件：质量6. M4S(R2): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Safety人用药物注册申请的通用技术文件：安全性7. M4E(R1): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Efficacy人用药物注册申请的通用技术文件：有效性8. M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals toLimit Potential Carcinogenic Risk为限制潜在致癌风险而对药物中DNA 活性(诱变性)杂质进行的评估和控制。
ICH指导原则目录
Q4 Pharmacopoeias(药典)
Q4
Pharmacopoeias
Q4A
Pharmacopoeial Harmonisation
Q4B
Step 5
2007-11-1
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
关于ICH区域内药典附录的评 价及建议-不溶性微粒检查法
Q4B
Annex 4A (R1)
Step 5
2010-9-27
Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
关于ICH区域内药典附录的评 价及建议-非无菌产品的微生物 检查：原料药及其制剂的判定 标准
Q4B Annex 5 (R1)
Step 5
2010-9-27
Disintegration Test General Chapter
关于ICH区域内药典附录的评 价及建议-崩解时限检查法
Q4B Annex 6
来源于人或动物细胞系的生物 技术产品的病毒安全性评价
Q5B
Step 5
1995-11-30
Quality of Biotechnological Products: Analysis of the Expression Construct in
Cells Used for Production of r-DNA Derived Protein Products
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Pesticide Analytical Manual Vol. I200–1Transmittal No. 98-1 (10/97)Form FDA 2905a (6/92)Table of Contentspagedate 201:Percentage Fat, Water, and Sugars in Foods 02: Grains 201-21/9409: Dairy 201-31/9412: Cheese201-31/9413: Ice Cream, etc.201-41/9414: Milk Products201-51/9415: Eggs and Egg Products 201-51/9416: Fish201-51/9417: Meat and Poultry 201-71/9420: Fruits201-81/9421: Fruit Products201-91/9422: Vine Fruits (Melons) and Products 201-101/9423: Nuts, Edible Seeds, and Products201-111/94Transmittal No. 98-1 (10/97)Form FDA 2905a (6/92)200–2Pesticide Analytical Manual Vol. Ipage date 24: Beans, Peas, Corn, and Fruiting Vegetables 201-111/9425: Vegetables and Products 201-141/9428: Spices, Flavors, and Salts 201-151/9436: Sweeteners (Nutritive)201-161/9438: Soups201-161/9440: Baby Foods201-161/94202:Basic Analytical Techniques 202 A:Introduction202-11/94202 B:Column Chromatography 202-11/94Terminology202-11/94Recommended Operating Procedure 202-21/94Common Problems 202-21/94202 C:Solvent Evaporation202-41/94Kuderna-Danish Concentrators 202-41/94Rotary Evaporator202-61/94Rotary Evaporator with Circulating 202-71/94Chilled Liquid Turbo-Vap202-81/94Common Problems 202-81/94References202-81/94203:Equipment and Procedures for Comminuting Samples 203 A:Equipment 203-11/94Blenders and Homogenizers 203-11/94Choppers and Food Processors 203-11/94Grinders 203-21/94Mills 203-21/94203 B:Procedures for Specific Commodities 203-21/94Crabs and Crayfish 203-21/94Eggs 203-31/94Fish 203-31/94Fruits and Vegetables 203-31/94Hays, Straws, and Dry, Low Fat 203-31/94Feed Ingredients Oilseeds 203-41/94Dry Products (Pasta, Dry Beans, Grains, etc.)203-41/94References 203-41/94204:Special Reagent Preparation 204 A:Introduction204-11/94204 B:PAM I Conventions for Reagents 204-11/94204 C:General Tests for Reagent Purity204-11/94Test for Substances Causing Determinative 204-11/94Step InterferencePesticide Analytical Manual Vol. I200–3Transmittal No. 98-1 (10/97)Form FDA 2905a (6/92)page date Test for Substances Causing Pesticide 204-21/94Degradation204 D:Tests and Purification Processes for 204-21/94Specific Reagents Acetonitrile 204-21/94Ethyl Ether 204-21/94Glass Wool 204-21/94Sodium Sulfate 204-31/94Florisil204-31/94Lauric acid test 204-41/94Elution test 204-59/96205:Reference Standards 205 A:Sources205-11/94205 B:Equipment and Solvents 205-11/94Equipment 205-11/94Solvents 205-21/94205 C:Storage 205-21/94205 D:Purity205-21/94205 E:Standard Solutions 205-31/94Definitions205-31/94Protocols for Preparing Standard Solutions 205-31/94205 F:Safety205-41/94205 G:Disposal of Reference Standards and Solutions 205-41/94206:Quality Assurance and Quality Control 206 A:General Principles 206-11/94206 B:QA Program Plan206-21/94Quality Control Points 206-21/94Quality of Equipment206-21/94Quality of Standards and Reagents 206-21/94Environmental Control/Facility 206-31/94Quality of Analytical Work206-31/94Quality of Analytical Documentation 206-31/94Audits206-41/94Sample Accountability206-41/94Quality of Administrative Systems 206-41/94206 C:SOPs206-41/94206 D:Bibliography206-61/94207:Safety207 A:Introduction207-11/94207 B:Laws and Regulations Related to Safety 207-11/94207 C:Material Safety Data Sheets207-21/94207 D:Development of a Chemical Hygiene Plan207-31/94Transmittal No. 98-1 (10/97)Form FDA 2905a (6/92)200–4Pesticide Analytical Manual Vol. Ipage date 207 E:Responsibilities of the Individual Chemist 207-51/94207 F:Role of Training 207-61/94207 G:Bibliography207-61/94Government or Organizational Materials 207-61/94Other Publications 207-71/94208:Hazardous Waste Disposal 208 A:Identification of Waste208-11/94Waste Specifically Excluded208-11/94Chemicals Listed in 40 CFR 261.30208-11/94Subpart DChemicals Exhibiting Hazardous Waste 208-21/94CharacteristicsHazardous Waste Mixtures208-31/94208 B:Categorization of Waste Generator 208-31/94208 C:Obtaining Appropriate ID Numbers208-31/94208 D:Waste Collection and Storage Procedures 208-41/94208 E:Arrangement for Waste Disposal208-41/94208 F:Additional Management Requirements 208-41/94208 G:Bibliography208-51/94Transmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201–1SECTION 201Pesticide Analytical Manual Vol. Ithis table provides percentage fat, water, and sugars for raw agricultural commodi-ties and some processed foods.Data were obtained from the following sources:USDA Nutrient Data Base for Standard Reference, Release 8 and Release 9,U.S. Department of Agriculture, Washington, DCHome Economics Research Report No. 48, “Sugar Content of Selected Foods: Individual and Total Sugars,” Tables 1, 3, and 4, Stock No. 001-000-04515-8, Government Printing Office, Washington, DC 20402; obtained by download from bulletin boardPehrsson, P. (Jan. 1994), private communication Smith, J.S., et al. (1986) J. Food Sci . 51, 1373-1375Notes on the information in this table:For the convenience of FDA field personnel, Office of Regulatory Affairs (ORA) product codes are included for most commodities, and commodi-ties are grouped by the same categories used to create the codes. (Product codes are those used in the FDA reporting system; these are not the same codes used by USDA to identify commodities in the Nutrient Data Base.)Within each subcategory, items are sorted alphabetically by name of the commodity.Names of commodities, including abbreviations, are those used by USDA Nutrient Data Base.Percentage sugars represents the sum of one or more mono- and disaccha-rides. Data are not available for all commodities, but the table will be updated in the future as data become available.For some commodities, sum of percent fat, water, and sugars may exceed 100%; this is caused by the fact that data were developed at different times on different samples.Product CodeCommodity % Fat % Water % SugarsSECTION 201Pesticide Analytical Manual Vol. ITransmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201-2* Percent sugars not available.02: GRAINSA: whole grain 02A-02barley, pearled, raw 1.1610.09*02A-99buckwheat groats, roasted, dry 2.718.41*02A-01corn, dry 2.0810*02A-99couscous, dry 0.648.56*02A-03oat bran, raw 7.03 6.55 1.402A-03oats 6.98.22*02A-04popcorn: unpopped 4.79.8*02A-07rye 2.510.95*02A-08sorghum 3.39.2*02A-06wild rice, raw 1.087.762.5B: corn meal & milled corn products 02B-01corn flour, masa, enriched 3.789.03*02B-01corn flour, whole-grain, white 3.8610.91*02B-01corn flour, whole-grain, yellow 3.8610.91*C: rice flour 02C-01rice flour, brown 2.7811.97*02C-01rice flour, white1.4211.891D: processed rice & milled rice products 02D-99rice bran, crude 20.85 6.130.902D-01rice, brown, long-grain, raw 2.9210.370.702D-01rice, brown, medium-grain, raw 2.6812.370.702D-10rice, white, glutinous, raw 0.5510.46*02D-03rice, white, long-grain, parboiled, dry, enriched 0.5610.16*02D-03rice, white, long-grain, precooked or instant, enriched, dry 0.298.14*02D-03rice, white, long-grain, regular, raw, enriched 0.6611.620.502D-02rice, white, medium-grain, cooked, enriched 0.2168.610.202D-03rice, white, medium-grain, raw, enriched 0.5812.890.502D-02rice, white, medium-grain, raw, unenriched 0.5812.890.502D-03rice, white, short-grain, raw, enriched 0.5213.29*F: milled wheat product 02F-04semolina, enriched1.0512.67*G: other flour/milled products 02G-02buckwheat 3.49.75*02G-02buckwheat flour, whole-groat 3.111.15*02G-10rye flour, dark 2.6911.07 3.502G-10rye flour, light 1.368.78 3.502G-10rye flour, medium1.779.85 3.5Transmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201–3Product CodeCommodity % Fat % Water % SugarsSECTION 201Pesticide Analytical Manual Vol. IH: starch products 02H-99arrowroot flour 0.111.37*02H-02cornstarch0.058.32*09: DAIRYA: butter products 09A-01butter, wo/salt 81.1117.94*09A-01butter: w/salt 81.1115.87*09A-01butter: whipped81.1115.87*C: milk/cream 09C-07cream: fluid, half & half, cream and milk 11.580.57*09C-13cream: fluid, heavy whipping 3757.71 2.809C-13cream: fluid, light whipping 30.9163.5 2.809C-13cream: fluid, light, coffee or table 19.3173.75*09C-13cream: fluid, medium, 25% fat 2568.5*09C-12cream: sour half & half, cultured 1280.14*09C-04eggnog 7.4874.37*09C-03milk: cow, cnd, condensed, sweetened 8.727.16*09C-03milk: cow, cnd, evaporated, unsweetened, w/added Vit. A 7.5674.04*09C-16milk: cow, dry, whole 26.71 2.4735.909C-09milk: cow, whole, past and raw, fluid, 3.3% fat 3.3487.99 4.909C-09milk: cow, whole, past and raw, fluid, 3.7% fat 3.6687.69 4.909C-12sour cream 20.9670.95*D: low fat milk product 09D-03milk: cow, cnd, evaporated, skim 0.279.4*09D-16milk: cow, dry, skim, calcium reduced 0.2 4.9*09D-16milk: cow, dry, skim, nonfat solids, instant, w/added Vit. A 0.72 3.9650.409D-09milk: cow, lowfat, past & raw, fluid, 1% fat 1.0690.08*09D-09milk: cow, lowfat, past & raw, fluid, 2% fat 1.9289.21*E: non-fat milk product 09E-01milk: buttermilk, fluid, cultured, from skim milk 0.8890.13 4.809E-16milk: cow, dry, skim, nonfat solids, regular, w/added Vit. A 0.77 3.16*09E-11milk: cow, skim, past & raw, fluid, w/added Vit. A0.1890.8 4.912: CHEESEA: standard cheese 12A-02cheese: natural, blue 28.7442.41*12A-03cheese: natural, brick 29.6841.11*12A-56cheese: natural, brie 27.6848.42*12A-56cheese: natural, camembert, domestic 24.2651.8*12A-57cheese: natural, caraway 29.239.28*12A-05cheese: natural, cheddar, American domestic 33.1436.75 1.812A-06cheese: natural, colby32.1138.2*Product CodeCommodity% Fat% Water% SugarsSECTION 201Pesticide Analytical Manual Vol. ITransmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201-412A-11cheese: natural, cottage, creamed, large or small curd 4.5178.960.612A-62cheese: natural, cottage, low fat, 1% fat 1.0282.48*12A-62cheese: natural, cottage, low fat, 2% fat1.9379.31*12A-09cheese: natural, cottage, uncreamed, dry, large or small curd 0.4279.77*12A-10cheese: natural, cream 34.8753.75 1.712A-12cheese: natural, edam 27.841.56*12A-16cheese: natural, gouda 27.4441.46*12A-18cheese: natural, gruyere 32.3433.19*12A-37cheese: natural, limburger 27.2548.42*12A-38cheese: natural, monterey 30.2841.01*12A-39cheese: natural, muenster 30.0441.77*12A-40cheese: natural, neufchatel23.4362.21112A-42cheese: natural, Parmesan, grated 30.0217.66*12A-52cheese: natural, port de salut 28.245.45*12A-44cheese: natural, provolone 26.6240.95*12A-47cheese: natural, romano 26.9430.91*12A-49cheese: natural, Roquefort30.6439.38*12A-60cheese: natural, Swiss, domestic 27.4537.21 1.212A-52cheese: natural, tilsit, whole milk25.9842.86*B: standard cheese products 12B-01cheese food: cold pack, American 24.4643.12*12B-09cheese food: pasteurized processed, Swiss 24.1443.67*12B-09cheese: pasteurized processed, American, w/di Na phos 31.2539.16*12B-13cheese: pasteurized processed, Swiss, w/di Na phos 25.0142.31*C: non-standard cheese products 12C-99cheese: natural, cheshire 30.637.65*12C-12cheese: natural, feta 21.2855.22*12C-04cheese: natural, fontina 31.1437.92*12C-99cheese: natural, gjetost 29.5113.44*12C-06cheese: natural, mozzarella, part skim milk 15.9253.78*12C-06cheese: natural, mozzarella, part skim milk, low moisture 17.1248.57*12C-06cheese: natural, mozzarella, whole milk 21.654.14*12C-06cheese: natural, mozzarella, whole milk, low moisture 24.6448.38*12C-11cheese: natural, ricotta, part skim milk 7.9174.41 1.412C-11cheese: natural, ricotta, whole milk12.9871.7 1.513: ICE CREAM, ETC.A: ice cream 13A-02ice cream: French, vanilla, soft serve 13.0259.76*13A-03ice cream: vanilla, regular, appx 10% fat 10.7760.817.513A-02ice cream: vanilla, rich, appx 16% fat 1658.8717.5C: ice milk 13C-01ice milk: vanilla, hardened4.368.62*Transmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201–5Product CodeCommodity% Fat% Water% SugarsSECTION 201Pesticide Analytical Manual Vol. I13C-99ice milk: vanilla, soft serve2.6469.64*D: sherbet 13D-01sherbet: orange1.9866.07*14: MILK PRODUCTSB: imitation milk products 14B-99cream substitute: nondairy, liquid, w/hydr veg oil & soy protein9.9777.27*14B-99cream substitute: nondairy, liquid, w/lauric acid oil & Na casn 9.9777.27*14B-06cream substitute: nondairy, powdered 35.482.21*15: EGGS AND EGG PRODUCTSA: shell eggs 15A-01eggs: chicken, white, raw, fresh and frozen 087.81*15A-01eggs: chicken, whole, raw, fresh, and frozen 10.0275.33*15A-03eggs: duck, whole, fresh, raw 13.7770.83*15A-99eggs: goose, whole, fresh, raw 13.2770.43*B: shelled egg products 15B-02eggs: chicken, yolk, dried 61.28 4.65*15B-02eggs: chicken, yolk, raw, fresh 30.8748.81*15B-02eggs: chicken, yolk, raw, frozen 26.0155*E: imitation/substitute egg products 15E-03egg substitute: frozen 11.1173.1*15E-99egg substitute: liquid 3.3182.75*15E-99egg substitute: powder13 3.86*16: FISHA: fish 16A-01fish/shellfish: anchovy, European, raw4.8473.370.016A-03fish/shellfish: bass, freshwater, mixed species, raw 3.6975.660.016A-03fish/shellfish: bass, striped, raw 2.3379.220.016A-05fish/shellfish: bluefish, raw 4.2470.860.016A-99fish/shellfish: burbot, raw 0.8179.260.016A-08fish/shellfish: butterfish, raw 8.0274.130.016A-09fish/shellfish: carp, raw5.676.310.016A-10fish/shellfish: catfish, channel, raw 4.2676.390.016A-48fish/shellfish: cisco, raw1.9178.930.016A-12fish/shellfish: cod, Atlantic, raw 0.6781.220.016A-12fish/shellfish: cod, Pacific, raw0.6381.280.016A-13fish/shellfish: croaker, Atlantic, raw 3.1778.030.016A-14fish/shellfish: cusk, raw0.6976.350.016A-51fish/shellfish: dolphinfish, raw0.777.550.016A-13fish/shellfish: drum, freshwater, raw 4.9377.330.016A-15fish/shellfish: eel, mixed species, raw11.6668.260.0Product CodeCommodity% Fat% Water% SugarsSECTION 201Pesticide Analytical Manual Vol. ITransmittal No. 94-1 (1/94)Form FDA 2905a (6/92)201-616A-16fish/shellfish: flatfish (flounder and sole species), raw 1.1979.060.016A-17fish/shellfish: grouper, mixed species, raw 1.0279.220.016A-18fish/shellfish: haddock, raw0.7279.920.016A-20fish/shellfish: halibut, Atlantic and Pacific, raw 2.2977.920.016A-20fish/shellfish: halibut, Greenland, raw 13.8470.270.016A-21fish/shellfish: herring, Atlantic, raw 9.0472.050.016A-21fish/shellfish: herring, Pacific, raw 13.8871.520.016A-99fish/shellfish: ling, raw 0.6479.630.016A-99fish/shellfish: lingcod, raw1.0681.030.016A-22fish/shellfish: mackerel, Atlantic, raw 13.8963.550.016A-22fish/shellfish: mackerel, king, raw275.850.016A-22fish/shellfish: mackerel, Pacific and jack, mixed species, raw 7.8970.150.016A-22fish/shellfish: mackerel, Spanish, raw 6.371.670.016A-53fish/shellfish: milkfish, raw 6.7370.850.016A-99fish/shellfish: monkfish, raw1.5283.240.016A-24fish/shellfish: ocean perch, Atlantic, raw 1.6378.70.016A-25fish/shellfish: pike, northern, raw 0.6978.920.016A-25fish/shellfish: pike, walleye, raw 1.2279.310.016A-28fish/shellfish: pollock, Atlantic, raw 0.9878.180.016A-28fish/shellfish: pollock, walleye, raw 0.881.560.016A-29fish/shellfish: pompano, Florida, raw 9.4771.120.016A-99fish/shellfish: pout, ocean, raw0.9181.360.016A-24fish/shellfish: rockfish, Pacific, mixed species, raw 1.5779.260.016A-50fish/shellfish: roughy, orange, raw 775.90.016A-31fish/shellfish: sablefish, raw15.371.020.016A-32fish/shellfish: salmon, Atlantic, raw 6.3468.50.016A-32fish/shellfish: salmon, chinook, raw 10.4473.170.016A-32fish/shellfish: salmon, chum, raw 3.7775.380.016A-32fish/shellfish: salmon, coho, raw 5.9572.630.016A-32fish/shellfish: salmon, pink, raw 3.4576.350.016A-32fish/shellfish: salmon, sockeye, raw 8.5670.240.016A-99fish/shellfish: scup, raw2.7375.370.016A-04fish/shellfish: sea bass, mixed species, raw 278.270.016A-47fish/shellfish: seatrout, mixed species, raw3.6178.090.016A-21fish/shellfish: shad, American, raw13.7768.190.016A-35fish/shellfish: shark, mixed species, raw 4.5173.580.016A-99fish/shellfish: sheepshead, raw 2.4177.970.016A-36fish/shellfish: smelt, rainbow, raw2.4278.770.016A-99fish/shellfish: snapper, mixed species, raw 1.3476.870.016A-39fish/shellfish: spot, raw4.975.950.016A-40fish/shellfish: sturgeon, mixed species, raw 4.0476.550.016A-41fish/shellfish: sucker, white, raw2.3279.710.016A-99fish/shellfish: sunfish, pumpkinseed, raw 0.779.50.016A-42fish/shellfish: swordfish, raw 4.0175.620.016A-99fish/shellfish: tilefish, raw2.3178.90.016A-44fish/shellfish: trout, mixed species, raw 6.6171.420.016A-44fish/shellfish: trout, rainbow, raw3.3671.480.0Code Commodity% Fat% Water% Sugars 16A-45fish/shellfish: tuna, fresh, bluefin, raw 4.968.090.0 16A-45fish/shellfish: tuna, fresh, skipjack, raw 1.0170.580.0 16A-45fish/shellfish: tuna, fresh, yellowfin, raw0.9570.990.0 16A-46fish/shellfish: turbot, European, raw 2.9576.950.0 16A-48fish/shellfish: whitefish, mixed species, raw 5.8672.770.0 16A-49fish/shellfish: whiting, mixed species, raw 1.3180.270.0 16A-99fish/shellfish: wolffish, Atlantic, raw 2.3979.90.0 16A-99fish/shellfish: yellowtail, mixed species, raw 5.2474.520.0 16A-02fish: barracuda, Pacific, raw 2.675.40.0E: shellfish16E-01fish/shellfish: abalone, mixed species, raw0.7674.56* 16E-02fish/shellfish: clam, mixed species, raw0.9781.82* 16E-04fish/shellfish: mussel, blue, raw 2.2480.58* 16E-03fish/shellfish: oyster, eastern, raw 2.4785.14* 16E-03fish/shellfish: oyster, Pacific, raw 2.382.06* 16E-05fish/shellfish: scallop, mixed species, raw0.7678.57* 16E-99fish/shellfish: whelk, unspecified, raw0.466* J: crustaceans16J-01fish/shellfish: crab, Alaska king, raw0.679.570.0 16J-01fish/shellfish: crab, blue, raw 1.0879.02* 16J-01fish/shellfish: crab, dungeness, raw0.9779.18* 16J-01fish/shellfish: crab, queen, raw 1.1880.580.0 16J-02fish/shellfish: crayfish, mixed species, raw 1.0680.790.0 16J-04fish/shellfish: lobster, northern, raw0.976.76* 16J-05fish/shellfish: shrimp, mixed species, raw 1.7375.86* 16J-03fish/shellfish: spiny lobster, mixed species, raw 1.5174.07* M: other aquatic animals16M-07fish/shellfish: cuttlefish, mixed species, raw0.780.56* 16M-09fish/shellfish: octopus, common, raw 1.0480.25* 16M-03fish/shellfish: squid, mixed species, raw 1.3878.55* 16M-01frog legs: raw0.381.90.0 16M-05seafood: terrapin, (diamond back), raw 3.5770.0 16M-05seafood: turtle, green, raw0.578.50.0 16M-06seafood: whale meat, raw7.570.9* R: engineered seafood16R-01fish/shellfish: surimi0.976.34*Y: fishery products16Y-04fish/shellfish: roe, mixed species, raw 6.4267.73*17: MEAT AND POULTRYA: red meat products17A-01frankfurters: raw, beef28.5454.71*Code Commodity% Fat% Water% Sugars 17A-99frankfurters: raw, beef & pork29.1553.872 17A-99goat: raw 2.3175.84* B: poultry/poultry products17B-99frankfurter: chicken19.4857.53* 17B-06frankfurter: turkey17.762.99* 20: FRUITSA: berries20A-01blackberries: raw0.3985.647.9 20A-02blueberries: raw0.3884.617.3 20A-04cranberries: raw0.286.54* 20A-05currants: European black, raw0.4181.968 20A-05currants: red and white, raw0.283.958 20A-07elderberries: raw0.579.8* 20A-08gooseberries: raw0.5887.87* 20A-09grapes: American type (slip skin), raw0.3581.316.4 20A-09grapes: European type (adherent skin), raw0.5880.5618.1 20A-99groundcherries: (cape-gooseberries or poha), raw0.785.4* 20A-99mulberries: raw0.3987.68* 20A-99oheloberries: raw0.2292.3* 20A-10raisins: golden seedless0.4614.97* 20A-10raisins: seeded0.5416.57* 20A-10raisins: seedless0.4615.4261.7 20A-13raspberries: raw0.5586.57* 20A-14strawberries: raw0.3791.57 5.7 D: berry juice20D-09grape juice: canned or bottled, unsweetened0.0884.1214.2 G: citrus fruit20G-02grapefruit: raw, pink/red/white, all areas0.190.89 6.2 20G-03kumquats: raw0.181.7* 20G-04lemon peel: raw0.381.6* 20G-04lemons: raw, w/peel0.387.4* 20G-05limes: raw0.288.260.4 20G-06oranges: raw, all commercial varieties0.1286.758.9 20G-06oranges: raw, California, navels0.0986.81* 20G-06oranges: raw, California, valencias0.386.34* 20G-06oranges: raw, Florida0.2187.148.9 20G-07pummelo: raw0.0489.1* 20G-09tangerines: (mandarin orange), raw0.1987.6* K: citrus fruit juices20K-02grapefruit juice: pink/red/white, all varieties, raw0.1907.5 20K-04lemon juice: canned or bottled0.2992.46 2.4 20K-04lemon juice: raw090.73 2.4Code Commodity% Fat% Water% Sugars 20K-05lime juice: canned or bottled, unsweetened0.2392.52* 20K-05lime juice: raw0.190.21* 20K-06orange juice: canned, unsweetened0.1489.019.8 20K-06orange juice: raw0.288.310.2N: core fruit20N-01apples: raw, w/skin0.3683.9311.5 20N-02crabapples: raw0.378.94* 20N-99mammy-apple: (mamey), raw0.586.2* 20N-03pears: raw0.483.8110.5 20N-05pricklypears: raw0.5187.55* 20N-04quinces: raw0.183.8* 20N-99rose-apples: raw0.393* Q: core fruit, dried/paste20Q-01apples: dehydrated (low moisture), sulfured, uncooked0.583* 20Q-01apples: dried, sulfured, uncooked0.3231.76* 20Q-01applesauce: canned, sweetened, w/salt0.1879.5816.5 S: core fruit juice20S-01apple juice: canned or bottled, unsweetened, w/added asc acid0.1187.9310.921: FRUIT PRODUCTSG: pit fruit21G-01apricots: raw0.3986.359.3 21G-02avocados: raw, California17.3372.560.9 21G-02avocados: raw, Florida8.8779.73* 21G-03cherries: sour, red, raw0.386.138.1 21G-03cherries: sweet, raw0.9680.7614.6 21G-05dates: domestic, natural and dry0.4522.564.2 21G-99java-plum: (jambolan), raw0.2383.13* 21G-16jujube: raw0.277.86* 21G-08loquats: raw0.286.73* 21G-07nectarines: raw0.4686.288.5 21G-13peaches: raw0.0987.668.7 21G-12pitanga: (surinam-cherry), raw0.490.81* 21G-14plums: raw0.6285.27.5 21G-99sapodilla: raw 1.178* H: pit fruit dried/paste21H-01apricots: dehydrated (low-moisture), sulfured, uncooked0.627.5* 21H-01apricots: dried, sulfured, uncooked0.4631.0938.9 K: pit fruit juice21K-01apricot nectar: canned, w/added asc acid0.0984.8713.5Code Commodity% Fat% Water% Sugars S: sub/tropical fruit21S-99balsam-pear: leafy tips, raw0.6989.250.8 21S-99balsam-pear: pods, raw0.1794.030.8 21S-02bananas: raw0.4874.2618.4 21S-02bananas: red, raw0.274.4* 21S-20carambola: (starfruit), raw0.3590.927.1 21S-99cherimoya: raw0.473.5* 21S-99custard-apple: (bullock’s-heart), raw0.671.5* 21S-03figs: raw0.379.11 6.9 21S-04guavas: common, raw0.686.16 21S-04guavas: strawberry, raw0.680.66* 21S-10jackfruit: raw0.373.2318.4 21S-11kiwifruit: (Chinese gooseberries), fresh, raw0.4483.058.9 21S-19litchis: raw0.4481.76* 21S-18longans: raw0.182.75* 21S-05mangoes: raw0.2781.7114.8 21S-06papayas: raw0.1488.83 5.9 21S-12passion-fruit: (granadilla), purple, raw0.772.9311.2 21S-07pineapple: raw0.4386.511.9 21S-08plantain: raw0.3765.28* 21S-16sapotes: (marmalade plum), raw0.662.43* 21S-09seeds: breadfruit seeds, boiled 2.359.3* 21S-09seeds: breadfruit seeds, raw 5.5956.27* 21S-14tamarinds: raw0.631.4* T: sub/tropical fruit dried/paste21T-19litchis: dried 1.222.3* 21T-18longans: dried0.417.6* V: sub/tropical fruit juice/milk,creme/nect21V-01acerola juice: raw0.394.3* 22: VINE FRUITS (MELONS) AND PRODUCTSA: vine fruit22A-01melons: cantaloupe, raw0.2889.788.1 22A-02melons: casaba, raw0.192* 22A-03melons: honeydew, raw0.189.66* 22A-04watermelon: raw0.4391.519 G: other fruit products22G-02persimmons: Japanese, raw0.1980.32* 22G-02persimmons: native, raw0.464.4* 22G-01pomegranate: raw0.380.978.9 22G-99roselle: raw0.6486.58* 22G-04soursop: raw0.381.16* 22G-05sugar-apples: (sweetsop), raw0.2973.23*Code Commodity% Fat% Water% Sugars 23: NUTS, EDIBLE SEEDS, AND PRODUCTSA: nut in shell23A-04nuts: chestnuts, European, raw, unpeeled 2.2648.6510.6 B: nut shelled23B-99nuts: acorns, raw23.8627.9* 23B-04nuts: chestnuts, Chinese, raw 1.1143.95* 23B-04nuts: chestnuts, European, raw, peeled 1.255211.3 23B-04nuts: chestnuts, Japanese, raw0.5361.41* 23B-05nuts: coconut meat, raw33.4946.99 3.5 23B-15nuts: ginkgo nuts, raw 1.6855.2* 23B-07peanuts: all types, raw49.24 6.5 4.3 23B-07peanuts: Spanish, raw49.6 6.39* 23B-07peanuts: Valencia, raw47.58 4.26* 23B-07peanuts: Virginia, raw48.75 6.91 4.3 C: nut butter23C-07nuts: peanut butter, w/salt added49.98 1.42* 23C-07peanut butter: chunk style, w/salt49.94 1.137.8 23C-07peanut butter: chunk style, wo/salt49.94 1.13* 23C-07peanut butter: smooth style, w/salt49.98 1.427.8 23C-07peanut butter: smooth style, wo/salt49.98 1.427.8 K: edible seed23K-08millet, raw 4.228.67 1.2 23K-09quinoa 5.89.3* 23K-06seeds: lotus seeds, raw0.5377* 23K-03soybeans: green, raw 6.867.5* 24: BEANS, PEAS, CORN, AND FRUITING VEGETABLESA: bean/pea/corn24A-01alfalfa seeds: sprouted, raw0.6991.140.2 24A-99beans: adzuki, mature seeds, raw0.5313.44* 24A-99beans: black turtle soup, mature seeds, raw0.911* 24A-16beans: black, mature seeds, raw 1.4211.02* 24A-04beans: cranberry (Roman), mature seeds, canned0.2877.56* 24A-99beans: French, mature seeds, raw 2.0210.77* 24A-10beans: great northern, mature seeds, raw 1.1410.7* 24A-99beans: hyacinth, mature seeds, raw 1.699.38* 24A-07beans: kidney, all types, mature seeds, raw0.8311.75* 24A-07beans: kidney, California red, mature seeds, raw0.2511.75* 24A-07beans: kidney, red, mature seeds, raw 1.0611.75* 24A-07beans: kidney, royal red, mature seeds, raw0.4511.9* 24A-08beans: lima, large, mature seeds, raw0.6910.178.5 24A-09beans: mung, mature seeds, raw 1.159.05 6.6 24A-01beans: mung, mature seeds, sprouted, raw0.1890.4 1.7 24A-99beans: mungo, mature seeds, raw 1.838.58*Code Commodity% Fat% Water% Sugars 24A-10beans: navy, mature seeds, raw 1.2812.36*24A-99beans: pink, mature seeds, raw 1.1310.06*24A-11beans: pinto, mature seeds, raw 1.1310.95*24A-99beans: small white, mature seeds, raw 1.1811.71*24A-14beans: snap, green var, raw0.1290.27 2.6 24A-15beans: snap, yellow var, raw0.1290.27*24A-10beans: white, mature seeds, raw0.8511.32*24A-99beans: winged, mature seeds, raw16.328.34724A-14beans: yardlong, mature seeds, raw 1.318.43*24A-99beans: yellow, mature seeds, raw 2.611.1*24A-05broadbeans (fava beans): mature seeds, raw 1.5310.98 5.7 24A-06chickpeas (garbanzo beans, bengal gram): mature seeds, raw 6.0411.53 3.8 24A-60corn, white 4.7410.37*24A-60corn, yellow 4.7410.37*24A-60corn: sweet, white, raw 1.1875.96*24A-60corn: sweet, yellow, raw 1.1875.96 5.4 24A-99cowpeas: catjang, mature seeds, raw 2.0711.05 3.0 24A-99hyacinth-beans: immature seeds, raw0.287.87*24A-70lentils: mature seeds, raw0.9611.19 2.5 24A-99lupins: mature seeds, raw9.7410.44*24A-99mothbeans: mature seeds, raw 1.619.68*24A-99natto1155.02*24A-51peas: edible-podded, raw0.288.89424A-51peas: green, raw0.478.86 4.5 24A-99peas: split, mature seeds, raw 1.1611.27*24A-17pigeon peas (red gram): mature seeds, raw 1.4910.59 2.8 24A-13soybeans: mature seeds, raw19.948.54 6.6 24A-99tempeh7.6854.95 1.3 24A-13tofu: raw, firm8.7269.830.4 24A-13tofu: raw, regular 4.7884.550.4 24A-99winged bean: leaves, raw 1.176.85*24A-99winged bean: tuber, raw0.957.4*24A-14yardlong bean: raw0.487.85* F: fruit (vegetable)24F-99chayote: fruit, raw (pear-shaped veg, squash family)0.393*24F-20cucumber: not pared, raw0.1396.05 2.3 24F-01eggplant: raw0.191.93 3.4 24F-09gourd: dishcloth (towelgourd), raw0.293.85*24F-09gourd: white-flowered (calabash), raw0.0295.54*24F-02okra: raw0.189.58 2.4 24F-08peppers: hot chili, green, raw0.287.74*24F-08peppers: hot chili, red, raw0.287.74*24F-07peppers: sweet, green, raw0.1992.19 2.5 24F-07peppers: sweet, red, raw0.1992.19*24F-05pumpkin: raw0.191.6 4.4 24F-06squash: summer, all varieties, raw0.2193.68 2.2。