N-乙酰氨基葡萄糖-USP38
氨基葡萄糖硫酸软骨素USP标准
USP 35Dietary Supplements / Glucosamine1333Staining reagent for 5 min. Then stir the solution gently Ginseng, American—see American Ginsengfor 1 min. Remove the membrane, and destain in 5%acetic acid until the background clears.Acceptance criteria: The principal spot of the Samplesolution has the same migration as the principal spot ofthe Standard solution.[N OTE—Document the results by taking a picture within Ginseng, Asian—see Asian Ginseng15 min of completion of destaining.]STRENGTH•C ONTENT OF G LUCOSAMINEDiluent: Transfer 29 µL of acetic acid and 5 mL of aceto-nitrile to a 100-mL volumetric flask containing 50 mL ofwater. Dilute with water to volume.Ginseng, Siberian—see EleutheroBorate buffer: 0.2 M (76.3 g/L of sodium borate inwater) adjusted with hydrochloric acid TS to a pH of 9.5Acetate buffer: 6.80 g/L of sodium acetate trihydrate inwater adjusted with dilute acetic acid to a pH of 5.9Derivatizing reagent: In a 14-mL polypropylene culturetube, dissolve 50 mg of o-phthalaldehyde in 1.25 mL ofanhydrous methanol. Add 50 µL of 3-mercaptopropionic Sodium Tablets acid and 11.2 mL of Borate buffer, and mix gently. Allowto stand in the dark for 30 min before use. [N OTE—Rea-DEFINITION gent strength is maintained by adding 10 µL of 3-mer-Glucosamine and Chondroitin Sulfate Sodium Tablets are captopropionic acid every 2 days. Storage should be in prepared from either Glucosamine Hydrochloride, Gluco-the dark at room temperature, and can be used for NMT samine Sulfate Sodium Chloride, Glucosamine Sulfate Po- 2 weeks.]tassium Chloride, or a mixture of any of them, with Mobile phase: Methanol and Acetate buffer (1:9) Chondroitin Sulfate Sodium. Tablets contain NLT 90.0%Standard solution: 1.0 mg/mL of USP Glucosamine Hy-and NMT 120.0% of the labeled amounts of chondroitin drochloride RS in water. Allow to stand at room temper-sulfate sodium and glucosamine (C6H13NO5).ature for 1 h.[N OTE—Chondroitin Sulfate Sodium is extremely hygro-Sample solution: Transfer an equivalent to 25 mg of scopic once dried. Avoid exposure to atmosphere, and glucosamine, from finely powdered Tablets (NLT 20), to weigh promptly.] a 25-mL volumetric flask. Dilute with Diluent to volume.Mix on a vortex mixer to suspend the powder in solu-IDENTIFICATION tion. Sonicate in a 65° water bath for 20 min. Remove •A. The retention time of the major peaks of the Sample from the bath, stir for 5 min with the aid of a magnetic solution correspond to those of the Standard solution, as stirrer, and centrifuge.obtained in the test for Content of Glucosamine.Chromatographic system•B. E LECTROPHORESIS〈726〉 (See Chromatography 〈621〉, System Suitability.)Barium acetate buffer: Dissolve 25.24 g of barium ace-Mode: LCtate in 900 mL of water. Adjust with acetic acid to a pH Detector: UV 340 nmof 5.0, and dilute with water to 1000 mL.Column: 3.0-mm × 5-cm; packing L1Staining reagent: 0.1% (w/v) toluidine blue in 0.1 M Flow rate: 1 mL/minacetic acid Injection size: 10 µLStandard solution: Use the Standard solution of middle System suitabilityconcentration from the test for Content of Chondroitin Samples: Five individual aliquots of the Standard solu-Sulfate Sodium.tion derivatized as directed in the Analysis. Each deriva-Sample solution: Prepare as directed in the test for Con-tized aliquot is injected only once.tent of Chondroitin Sulfate Sodium.[N OTE—The relative retention times for the β-anomer Analysis: Fill the chambers of an electrophoresis appara-and the α-anomer are 1.0 and 1.8, respectively. The tus suitable for separations on cellulose acetate mem-retention time for the β-anomer is NLT 4 min.] branes1 (a small submarine gel chamber or one dedi-Suitability requirementscated to membrane media) with Barium acetate buffer.Relative standard deviation: NMT 2.0% from five Soak a cellulose acetate membrane 5–6 cm × 12–14 cm replicate injectionsin Barium acetate buffer for 10 min, or until evenly wet-Analysisted, then blot dry between two sheets of absorbent pa-Samples:Standard solution and Sample solutionper. Using an applicator2 suitable for electrophoresis, ap-Transfer 100 µL of the Derivatizing reagent and 100 µL of ply equal volumes (0.5 µL) of the Sample solution and the Standard solution or Sample solution to a vial con-Standard solution to the brighter side of the membrane taining 400 µL of Borate buffer. Allow the derivatization held in position in an appropriate applicator stand or on to proceed for 1 min. Inject the derivatized solutionsa separating bridge in the chamber. Ensure that both immediately after the derivatization reaction.ends of the membrane are dipped at least 0.5–1.0 cm Calculate the percentage of the labeled amount of glu-deep into the buffer chambers. Apply a constant 60 V (6cosamine (C6H13NO5) in the portion of Tablets taken: mA at the start) for 2 h. [N OTE—Perform the applicationof solutions and voltage within 5 min because further Result = (r U/r S) × (C S/C U) × (M r1/M r2) × 100 drying of the blotted paper reduces sensitivity.]Place the membrane in a plastic staining tray, and with r U= peak response of the β-anomer from the the application side down, float or gently immerse in derivatized Sample solutionr S= peak response of the β-anomer from the1Suitable cellulose acetate membranes for electrophoresis are available from derivatized Standard solutionMalta Chemetron SRL, Milano, Italy (); FlukaChemical Corp., Milwaukee, WI; and DiaSys Corp., Waterbury, CT C S= concentration of USP Glucosamine().Hydrochloride RS in the Standard solution2Suitable applicators are available from DiaSys Corp., Waterbury, CT(mg/mL)() and Helena Laboratories, Beaumont, TX().1334Glucosamine / Dietary Supplements USP 35C U= nominal concentration of glucosamine in the Calculate the percentage of the labeled amount ofSample solution (mg/mL)glucosamine (C6H13NO5) dissolved: M r1= molecular weight of glucosamine, 179.17Result = (r U/r S) × (C S×V/L) × (M r1/M r2) × 100 M r2= molecular weight of glucosaminehydrochloride, 215.63r U= peak area from the derivatized Sample solution Acceptance criteria: 90.0%–120.0%r S= peak area from the derivatized Standard•C ONTENT OF C HONDROITIN S ULFATE S ODIUMsolutionDiluent: Weigh about 297 mg of monobasic potassiumC S= concentration of USP Glucosaminephosphate, 492 mg of dibasic potassium phosphate, andHydrochloride RS in the Standard solution 250 mg of polysorbate 80, and transfer into a 1-L(mg/mL)beaker. Dissolve in approximately 900 mL of water, andV= volume of Medium, 900 mL adjust with potassium hydroxide or phosphoric acid to aL= label claim of glucosamine (mg/Tablet) pH of 7.0 ± 0.2. Dilute with water to 1 L, and mixM r1= molecular weight of glucosamine, 179.17 thoroughly.M r2= molecular weight of glucosamineStandard solutions: 1.5, 1.0, and 0.5 mg/mL of USPhydrochloride, 215.63 Chondroitin Sulfate Sodium RS in waterTolerances: NLT 75% of the labeled amount of Sample solution: Transfer an equivalent to 100 mg ofglucosamine (C6H13NO5) is dissolved.chondroitin sulfate sodium, from finely powdered TabletsDetermine the percentage of the labeled amount of (NLT 20), to 60 mL of water. Shake to suspend thechondroitin sulfate sodium dissolved by using the powder in solution. Sonicate in a 65° water bath for 20following method.min. Remove from the bath, and stir or shake for 5 min.Standard solutions, Titrant, and Diluent: Proceed as Dilute with water to 100 mL, and centrifuge or passdirected in the test for Content of Chondroitin Sulfate through a suitable filter.Sodium.Titrimetric systemSample solution: Use the solution under test.(See Titrimetry 〈541〉.)Analysis: Proceed as directed in the test for Content of Mode: Photometric titrationChondroitin Sulfate Sodium.Titrant: 1 mg/mL of cetylpyridinium chloride in water.Calculate the percentage of the labeled amount of Degas before use.chondroitin sulfate sodium dissolved: Endpoint detection: Turbidimetric with a photoelectricprobeResult = (C×V/L) × 100AnalysisSamples:Standard solutions and Sample solution C= determined concentration of chondroitin Transfer 5.0 mL of each Standard solution and the sulfate sodium in the Sample solutionSample solution to separate titration vessels. Add 25(mg/mL)mL of Diluent to each. Stir until a steady reading is V= volume of Medium, 900 mLobtained with a photoelectric probe either at 420,L= label claim of chondroitin sulfate sodium550, or 660 nm. Set the instrument to zero in(mg/Tablet)absorbance mode. Titrate with Titrant using the Tolerances: NLT 75% of the labeled amount ofphotoelectric probe to determine the endpoint chondroitin sulfate sodium is dissolved.turbidimetrically. From a linear regression equation•W EIGHT V ARIATION OF D IETARY S UPPLEMENTS〈2091〉: Meet calculated using the volumes of Titrant consumed the requirementsversus concentrations of the Standard solutions,determine the concentration of chondroitin sulfate ADDITIONAL REQUIREMENTSsodium in the Sample solution.•P ACKAGING AND S TORAGE: Preserve in tight, light-resistant Calculate the percentage of the labeled amount of containers.chondroitin sulfate sodium in the portion of Tablets•L ABELING: The label indicates the types of glucosamine taken:salts contained in the article and the species source fromwhich the chondroitin was derived. Label it to state the Result = (C/C U) × 100source(s) of chondroitin sulfate sodium, whether bovine,porcine, avian, or a mixture of any of them. The label C= determined concentration of chondroitin states on the front panel the content of chondroitinsulfate sodium in the Sample solution sulfate sodium on the dried basis.(mg/mL)•USP R EFERENCE S TANDARDS〈11〉C U= nominal concentration of chondroitin sulfate USP Chondroitin Sulfate Sodium RSsodium in the Sample solution (mg/mL)USP Glucosamine Hydrochloride RSAcceptance criteria: 90.0%–120.0%PERFORMANCE TESTS•D ISINTEGRATION AND D ISSOLUTION OF D IETARY S UPPLEMENTS〈2040〉: Meet the requirements for Dissolution Glucosamine HydrochlorideMedium: Water; 900 mLApparatus 2: 75 rpmTime: 60 minDetermine the percentage of the labeled amount ofglucosamine (C6H13NO5) dissolved by using thefollowing method.Standard solution: Prepare as directed in the test forContent of Glucosamine. Dilute with a suitable quantity ofwater, if necessary.C6H13NO5·HCl215.63 Sample solution: Use the solution under test.D-Glucose, 2-amino-2-deoxy-, hydrochloride;Borate buffer, Acetate buffer, Derivatizing reagent,2-Amino-2-deoxy-β-D-glucopyranose hydrochloride [66-84-Mobile phase, and Chromatographic system: Proceed2].as directed in the test for Content of Glucosamine.Analysis: Proceed as directed in the test for Content ofGlucosamine.。
昆虫生长调节剂的种类和作用机理
昆虫生长调节剂的种类和作用机理摘要：昆虫生长调节剂是通过干扰昆虫正常生长发育，致使昆虫个体活动能力下降或死亡，从而导致种群灭绝的一类特异性杀虫剂。
本文综合介绍昆虫生长调节剂的发展概况，详述保幼激素类似物、蜕皮激素类似物、几丁质合成抑制种类及其开发应用研究情况，并对其毒理作用机制进行了论述，目前研究表明该类药剂对害虫具高效，对环境污染小，保护害虫天敌，具有明显的选择活性。
昆虫生长调节剂虽然发展缓慢，但是应用前景广阔。
关键词：昆虫生长调节剂；毒理机制；研究应用1. 昆虫生长调节剂的发展概况昆虫生长调节剂(Insect Growth Regulators)是通过抑制昆虫生理发育，如抑制蜕皮、抑制新表皮形成、抑制取食等导致害虫死亡的一类药剂。
1967年威廉姆斯提出以保幼激素(JH)及蜕皮激素(MH)为主的昆虫生长调节剂作为第三代杀虫剂。
1985年赵善欢认为昆虫生长调节剂应包括保幼激素(JH)、蜕皮激素(MH)及其类似物、抗保幼激素(JH)、几丁质合成抑制剂、植物源次生物的拒食剂、昆虫源信息素、引诱剂等干扰害虫行为及抑制生长发育特异性作用的缓效型“软农药”，从而拓宽了昆虫生长调节剂的范畴。
由于应用此类药剂有利于无公害绿色食品生产，符合人们保护生态要求，曾一度广泛受到人们的关注，并进行开发研究。
后因第二代有机合成杀虫剂(有机磷类、氨基甲酸酯类和拟除虫菊酯类杀虫剂)能高效、经济地防治害虫，致使昆虫生长调节剂步入低谷。
但随着“农药万能论”思潮的蔓延，“3R”不断加剧，人们对农药的概念又从“杀生物剂”转向寻找“生物合理农药”或“环保和谐农药”的新型杀虫剂，昆虫生长调节剂重新得到重视。
由于其作用机理不同于以往作用于神经系统的传统杀虫剂，毒性低、污染少、对天敌和有益生物影响小，有助于可持续农业的发展，有利于无公害绿色食品生产，有益于人类健康，因此被誉为“第三代农药”、“二十一世纪的农药”、“非杀生性杀虫剂”、“生物调节剂” ,“特异性昆虫控制剂”，由于它们符合人类保护生态环境的总目标，迎合各国政府和各阶层人民所关注的农药污染的解决途径这一热点，成为全球农药研究与开发的一个重点领域。
n乙酰氨基葡萄糖合成法和发酵法
文章标题：N-乙酰氨基葡萄糖合成法与发酵法探析序随着生物技术的发展和应用，糖类产品的生产方式也在不断创新。
其中，N-乙酰氨基葡萄糖是一种重要的生物化学产品，广泛应用于医药、食品和化工等领域。
在其生产过程中，合成法和发酵法是两种重要的生产方式。
本文将对这两种生产方式进行全面评估，从而探讨N-乙酰氨基葡萄糖的生产过程和技术发展，以期帮助读者更好地理解和应用这一领域的知识。
一、N-乙酰氨基葡萄糖的重要性1. 对N-乙酰氨基葡萄糖的介绍N-乙酰氨基葡萄糖（简称GlNAc）是一种重要的氨基糖类化合物，其分子结构中含有葡萄糖和乙酰胺基团。
在生物体内，GlNAc参与多种生物化学反应，具有重要的生物学功能，如参与细胞信号传导、细胞骨架蛋白修饰等。
GlNAc也是一种广泛应用的医药、食品和化工原料，其需求量不断增长。
2. N-乙酰氨基葡萄糖的生产需求随着GlNAc在医药和食品工业中的应用越来越广泛，其生产需求也在不断增加。
为了满足市场需求，研究人员提出了多种生产方式，其中合成法和发酵法是最为重要的两种方法。
二、N-乙酰氨基葡萄糖的合成法1. 合成法的原理合成法是指通过化学合成的方式制备GlNAc，其原理是利用化学合成反应将氨基葡萄糖和乙酰化合物进行反应，得到目标产物。
这种方法具有反应条件严格、产物纯度高等优点，是目前应用较广泛的生产方式之一。
2. 合成法的优缺点在使用合成法制备GlNAc时，常见的优点是反应条件控制容易、产物纯度高，适用于大规模工业生产。
然而，合成法也存在着原料成本高、环境影响大等缺点，制约了其在可持续发展中的应用。
三、N-乙酰氨基葡萄糖的发酵法1. 发酵法的原理发酵法是指利用微生物生物转化的方式制备GlNAc，其原理是将适合的原料通过发酵反应，使微生物菌种生产出GlNAc。
这种方法具有原料利用率高、环境友好等优点，受到了越来越多的关注。
2. 发酵法的优缺点使用发酵法制备GlNAc时，常见的优点是原料利用率高、环境友好，适用于可持续发展。
n乙酰氨基葡萄糖团体标准
n乙酰氨基葡萄糖团体标准
N-乙酰氨基葡萄糖的团体标准详细说明如下：
1. 标准制定单位：中国生物发酵产业协会。
2. 标准发布时间：2022年12月24日。
3. 标准名称：《N-乙酰氨基葡萄糖（发酵法）》（T/CBFIA 07002-2022）。
4. 标准主要内容：该团体标准适用于以葡萄糖为主要原料，经微生物发酵转化为N-乙酰氨基葡萄糖，再通过精制工艺得到的N-乙酰氨基葡萄糖的生产、检验和销售。
5. 标准实施时间：2023年4月1日起实施。
以上是关于N-乙酰氨基葡萄糖团体标准的详细说明，如需了解更多信息，请查阅官方网站或咨询专业人士。
USP38-通用章节目录
USP38-通用章节(zhāngjié)目录USP38-通用章节(zhāngjié)目录Guide to General Chapters 通用(tōngyòng)章节指导General Requirements for Test and Assays检查(jiǎnchá)与含量(hánliàng)分析的一般(yībān)要求＜1＞INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS 注射和植入药物(yàowù)产品(注射用) —产品质量测试＜1＞INJECTIONS注射剂＜2＞ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 口服药物产品质量测试＜3＞TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 局部和透皮药物产品—产品质量测试＜4＞MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 粘膜药物产品质量测试＜5＞INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS 吸入剂产品—产品质量测试＜7＞LABELING 标签＜11＞USP REFERENCE STANDARDS USP标准品Apparatus for Test and Assays用于检查与含量分析的器具＜17＞PRESCRIPTION CONTAINER LABELING处方容器(róngqì)标签＜21＞THERMOMETERS温度计＜31＞VOLUMETRIC APPARATUS容量(róngliàng)器具＜41＞BALANCES天平(tiānpíng)Microbiological Tests 微生物检查法＜51＞ANTIMICROBIAL EFFECTIVENESS TESTING抗菌剂有效性检查法＜55＞BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS生物(shēngwù)指示剂－耐药性实验(shíyàn)＜61＞MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS非无菌产品的微生物限度检查：微生物列举检查法＜62＞MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS 非无菌产品的微生物限度检查：特定微生物检查法＜63＞MYCOPLASMA TESTS 支原体检查法＜71＞STERILITY TESTS无菌检查法Biological tests and assays生物检查法与测定法＜81＞ANTIBIOTICS—MICROBIAL ASSAYS抗生素－微生物测定(cèdìng)＜85＞BACTERIAL ENDOTOXINS TEST细菌(xìjūn)内毒素检查法＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO体外的生物(shēngwù)反应性检查法＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO 体内(tǐ nèi)的生物反应性检查法＜89＞ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING药品(yàopǐn)生产中酶作为辅料所使用＜90＞FETAL BOVINE SERUM—QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS 牛胎儿血清-质量品质和功能检查法＜91＞CALCIUM PANTOTHENATE ASSAY泛酸钙测定法＜92＞GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MANUFACTURING 在细胞疗法中使用生长因子和细胞因子＜111＞DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS 生物测定法的设计与分析＜115＞DEXPANTHENOL ASSAY右泛醇（拟胆碱(d ǎn jiǎn)药）测定法＜121＞INSULIN ASSAYS胰岛素测定法＜121.1＞PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS胰岛素的物理化学(wù lǐ huà xué)分析程序＜123＞GLUCAGON BIOIDENTITY TESTS 高血糖素的生物(shēngwù)鉴别检查法＜124＞ERYTHROPOIETIN BIOASSAYS 红细胞生成素的微生物测定(cèdìng)＜126＞SOMATROPIN BIOIDENTITY TESTS 生长激素(shēnɡ chánɡ jī sù)的生物鉴别检查法＜130＞PROTEIN A QUALITY ATTRIBUTES 蛋白质A的质量特征＜151＞PYROGEN TEST热原检查法＜161＞TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES 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化学实验检查与测定法鉴别检查＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES鉴别(jiànbié)－有机氮碱化合物＜191＞IDENTIFICATION TESTS—GENERAL鉴别实验(shíyàn)－通用＜193＞IDENTIFICATION—TETRACYCLINES鉴别(jiànbié)－四环素类＜197＞SPECTROPHOTOMETRIC IDENTIFICATION TESTS分光(fēn ɡuānɡ)光度计鉴别实验(shíyàn)＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST薄层色谱鉴别实验Limit Tests 限度检查法＜206＞ALUMINUM铝＜207＞TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM依诺肝素钠的酐类衍生物实验＜208＞ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS普通肝素和低分子肝素产品中抗体Xa和抗体IIa测定＜209＞LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS低分子(fēnzǐ)肝素钠分子量测定＜211＞ARSENIC砷＜221＞CHLORIDE AND SULFATE氯和硫＜223＞DIMETHYLANILINE二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE4－？－四环素＜227＞4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS对乙酰氨酚药物产品(chǎnpǐn)中氨基酚＜228＞ETHYLENE OXIDE AND DIOXANE 环氧乙烷和二氧六环＜231＞HEAVY METALS重金属（删除(shānchú)）＜232＞ELEMENTAL IMPURITIES—LIMITS 元素(yuán sù)杂质-限度(xiàndù)＜233＞ELEMENTAL IMPURITIES—PROCEDURES 元素杂质-规程＜241＞IRON铁＜251＞LEAD铅＜261＞MERCURY汞＜267＞POROSIMETRY BY MERCURY INTRUSION 水银(shuǐyín)孔隙仪＜268＞POROSITY BY NITROGEN ADSORPTION–DESORPTION 氮吸附(xīfù)-解吸测定孔隙率＜271＞READILY CARBONIZABLE SUBSTANCES TEST易碳化物检查法＜281＞RESIDUE ON IGNITION炽灼(chì zhuó)残渣(cán zhā)＜291＞SELENIUM硒Other Tests and Assays 其它(qítā)检查法与测定法＜301＞ACID-NEUTRALIZING CAPACITY酸中和容量＜311＞ALGINATES ASSAY藻酸盐测定法＜341＞ANTIMICROBIAL AGENTS—CONTENT 抗菌剂－含量＜345＞Assay for Citric Acid/Citrate and Phosphate 柠檬酸/柠檬酸盐和磷酸盐的测定＜351＞ASSAY FOR STEROIDS类固醇（甾类化合物）测定法＜361> BARBITURATE ASSAY 巴比妥类药物测定法＜371＞COBALAMIN RADIOTRACER ASSAY钴铵素放射性跟踪剂测定法＜381＞ELASTOMERIC CLOSURES FOR INJECTIONS 注射剂的弹性(tánxìng)密封件＜391＞EPINEPHRINE ASSAY肾上腺素测定法＜401＞FATS AND FIXED OILS脂肪(zhīfáng)与混合油＜411＞FOLIC ACID ASSAY叶酸(yè suān)测定法＜413＞IMPURITIES TESTING IN MEDICAL GASES 医用气体(qìtǐ)杂质检查＜415＞MEDICAL GASES ASSAY 医用气体含量(hánliàng)检查＜425＞IODOMETRIC ASSAY—ANTIBIOTICS碘量检查法－抗生素＜429＞LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE粒径的光衍射测量法＜431＞METHOXY DETERMINATION甲氧基测定法＜441＞NIACIN OR NIACINAMIDE ASSAY 烟酰或烟酰胺测定法＜451＞NITRITE TITRATION亚硝酸盐滴定＜461＞NITROGEN DETERMINATION氮测定法＜466＞ORDINARY IMPURITIES一般杂质＜467＞RESIDUAL SOLVENTS残留溶剂＜469＞ETHYLENE GLYCOL, DIETHYLENEGLYCOL, AND TRIETHYLENE GLYCOLIN ETHOXYLATED SUBSTANCES 乙氧基物质(wùzhì)中乙二醇、二甘醇、三甘醇测定＜471＞OXYGEN FLASK COMBUSTION氧瓶燃烧(ránshāo)法＜481＞RIBOFLAVIN ASSAY核黄素（维生素B2）测定法＜501＞SALTS OF ORGANIC NITROGENOUS BASES有机(yǒujī)氮盐＜503＞ACETIC ACID IN PEPTIDES 多肽(duō tài)类中乙酸测定＜511＞SINGLE-STEROID ASSAY单一(dānyī)的类固醇测定法＜525＞SULFUR DIOXIDE 二氧化硫＜531＞THIAMINE ASSAY硫胺素测定法＜541＞TITRIMETRY滴定法＜551＞VITAMIN E ASSAY维生素E测定法＜561＞ARTICLES OF BOTANICAL ORIGIN植物起源的药品＜563＞IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN植物药品的鉴别＜565＞BOTANICAL EXTRACTS植物(zhíwù)提取＜571＞VITAMIN A ASSAY维生素A测定法＜581＞VITAMIN D ASSAY维生素D测定法＜591＞ZINC DETERMINATION锌的测定法Physical Test and Determinations物理(wùlǐ)检查(jiǎnchá)与测定法＜601＞INHALATION AND NASAL DRUGPRODUCTS: AEROSOLS, SPRAYS, ANDPOWDERS—PERFORMANCE QUALITYTESTS吸入剂、鼻雾剂：气溶胶，喷雾，干粉(gānfěn)-质量(zhìliàng)通则＜602＞PROPELLANTS 推进剂＜603＞TOPICAL AEROSOLS 局部喷雾剂＜604＞LEAK RATE 渗漏率＜610＞ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR NONSTERILEINHALED AND NASAL PRODUCTS 非无菌吸入和鼻雾剂可供选择的微生物取样方法＜611＞ALCOHOL DETERMINATION乙醇测定法＜616＞BULK DENSITY AND TAPPED DENSITY堆密度与振实密度＜621＞CHROMATOGRAPHY色谱法＜631＞COLOR AND ACHROMICITY呈色与消色＜641＞COMPLETENESS OF SOLUTION溶解度＜643＞TOTAL ORGANIC CARBON总有机(yǒujī)碳＜645＞WATER CONDUCTIVITY水电导率＜651＞CONGEALING TEMPERATURE凝点温度(wēndù)＜659＞PACKAGING AND STORAGE REQUIREMENTS 包装和储藏(chǔcáng)要求＜660＞CONTAINERS—GLASS 容器(róngqì)-玻璃＜661＞CONTAINERS—PLASTICS容器(róngqì)-塑料＜670＞AUXILIARY PACKAGING COMPONENTS 辅助包装部件＜671＞CONTAINERS—PERFORMANCE TESTING 容器－性能测试＜691＞COTTON棉花＜695＞CRYSTALLINITY结晶度＜696＞CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY AND SOLUTION CALORIMETRY 通过溶液量热学测定结晶性＜697＞CONTAINER CONTENT FOR INJECTIONS 注射剂容器容积＜698＞DELIVERABLE VOLUME抽取体积＜699＞DENSITY OF SOLIDS固体(gùtǐ)密度＜701＞DISINTEGRATION崩解(bēnɡ jiě)时限(shíxi àn)＜705＞QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE ？＜711＞DISSOLUTION 溶出度＜721＞DISTILLING RANGE馏程＜724＞DRUG RELEASE药物(yàowù)释放度＜729＞GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS脂类可注射(zhùshè)的乳剂的粒径分布＜730＞Plasma Spectrochemistry 血浆光谱化学？＜731＞LOSS ON DRYING4干燥失重＜733＞LOSS ON IGNITION灼烧失重＜735＞X-RAY FLUORESCENCE SPECTROMETRY X射线光谱＜736＞MASS SPECTROMETRY 质谱＜741＞MELTING RANGE OR TEMPERATURE熔距或熔点＜751＞METAL PARTICLES IN OPHTHALMIC OINTMENTS眼用软膏中的金属粒子＜755＞MINIMUM FILL最低装量＜761＞NUCLEAR MAGNETIC RESONANCE核磁共振(hé cíɡònɡ zhèn)＜771＞OPHTHALMIC OINTMENTS眼用软膏(ruǎngāo)＜776＞OPTICAL MICROSCOPY光学(guāngxué)显微镜＜781＞OPTICAL ROTATION旋光度＜785＞OSMOLALITY AND OSMOLARITY渗透压＜786＞PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING筛分(shāi fēn)法估算粒径分布(fēnbù)＜787＞SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS显微计数法在治疗性蛋白注射剂中应用＜788＞PARTICULATE MATTER IN INJECTIONS注射剂中的不溶性微粒＜789＞PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS眼用溶液中的不溶性微粒＜790＞VISIBLE PARTICULATES IN INJECTIONS 注射剂中可见异物＜791＞pH＜795＞PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS药物混合－非无菌制剂＜797＞PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS药物混合(hùnhé)－无菌制剂＜801＞POLAROGRAPHY极谱法＜811＞POWDER FINENESS粉剂(fěn jì)细度＜821＞RADIOACTIVITY放射性＜823＞POSITRON EMISSION TOMOGRAPHY DRUGS FOR COMPOUNDING,INVESTIGATIONAL, AND RESEARCHUSES用于正电子发射(fāshè)断层造影(zàoyǐng)术的放射性药物(yàowù)＜831＞REFRACTIVE INDEX折光率＜841＞SPECIFIC GRAVITY比重＜846＞SPECIFIC SURFACE AREA 比表面积＜851＞SPECTROPHOTOMETRY AND LIGHT-SCATTERING分光光度计与光散射＜852＞ATOMIC ABSORPTION SPECTROSCOPY 原子吸收光谱＜853＞FLUORESCENCE SPECTROSCOPY 荧光光谱＜854＞MID-INFRARED SPECTROSCOPY 中红外光谱＜857＞ULTRAVIOLET-VISIBLE SPECTROSCOPY 紫外可见(kějiàn)光谱＜861＞SUTURES—DIAMETER缝线(fénɡ xiàn)－直径？＜871＞SUTURES—NEEDLE ATTACHMENT缝线(fénɡ xiàn)－穿孔(chuānkǒng)实验＜881＞TENSILE STRENGTH张力(zhānglì)＜891＞THERMAL ANALYSIS热分析＜905＞UNIFORMITY OF DOSAGE UNITS制剂单位的含量均匀度＜911＞VISCOSITY—CAPILLARY METHODS黏度-毛细管法＜912＞VISCOSITY—ROTATIONAL METHODS 黏度-旋转法＜913＞VISCOSITY—ROLLING BALL METHOD 黏度-球法＜921＞WATER DETERMINATION水分测定＜941＞CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDSBY X-RAY POWDER DIFFRACTION (XRPD)X光衍射General Information通用信息＜1005＞ACOUSTIC EMISSION 声频发射＜1010＞ANALYTICAL DATA—INTERPRETATION AND TREATMENT分析数据(shùjù)－解释与处理＜1015＞AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS放射性自动合成装置(zhuāngzhì)＜1024＞BOVINE SERUM 牛血清(xuèqīng)＜1027＞FLOW CYTOMETRY 流式细胞仪＜1030＞BIOLOGICAL ASSAY CHAPTERS—OVERVIEW AND GLOSSARY生物测定章节(zhāngjié)-综述和术语＜1031＞THE BIOCOMPATIBILITY OFMATERIALS USED IN DRUGCONTAINERS, MEDICAL DEVICES, ANDIMPLANTS用于药物容器(róngqì)、医疗设施和植入剂的材料的生物相容性＜1034＞ANALYSIS OF BIOLOGICAL ASSAYS 生物测定分析＜1035＞BIOLOGICAL INDICATORS FOR STERILIZATION灭菌用生物指示剂＜1041＞BIOLOGICS生物制剂＜1043＞Ancillary Material for Cell, Gene, and Tissue-Engineered Products细胞，基因与组织(zǔzhī)设计产品的辅助材料＜1044＞CRYOPRESERVATION OF CELLS 细胞低温(dīwēn)保存＜1045＞BIOTECHNOLOGY-DERIVED ARTICLES 生物(shēngwù)技术提取产品＜1046＞CELLULAR AND TISSUE-BASED PRODUCTS细胞(xìbāo)与组织(zǔzhī)产品＜1047＞GENE THERAPY PRODUCTS 基因治疗产品＜1048＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FORPRODUCTION OF r-DNA DERIVED PROTEINPRODUCTS生物技术产品的质量：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 BIOTECHNOLOGICALPRODUCTS: STABILITY TESTING OFBIOTECHNOLOGICAL/BIOLOGICALPRODUCTS生物技术(jìshù)产品的质量：生物技术/生物产品的稳定性实验＜1050＞VIRAL SAFETY EVALUATION OFBIOTECHNOLOGY PRODUCTS DERIVEDFROM CELL LINES OF HUMAN ORANIMAL ORIGIN从人或动物细胞中提取的生物技术产品(chǎnpǐn)的病毒安全性评估＜1051＞CLEANING GLASS APPARATUS玻璃(bōlí)容器的清洗＜1052＞BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS生物(shēngwù)技术提取法-氨基酸测定＜1053＞CAPILLARY ELECTROPHORESIS 毛细管电泳(diàn yǒnɡ)法＜1054＞BIOTECHNOLOGY-DERIVED ARTICLES—ISOELECTRIC FOCUSING生物技术提取法-等电点聚集＜1055＞BIOTECHNOLOGY-DERIVED ARTICLES—PEPTIDE MAPPING生物技术提取法-肽谱＜1056＞BIOTECHNOLOGY-DERIVED ARTICLES—POLYACRYLAMIDE GEL ELECTROPHORESIS 生物(shēngwù)技术提取法-凝胶电泳＜1057＞BIOTECHNOLOGY-DERIVED ARTICLES—TOTAL PROTEIN ASSAY生物(shēngwù)技术提取法-总蛋白测定＜1058＞ANALYTICAL INSTRUMENT QUALIFICATION 分析仪器要求(yāoqiú)＜1059＞EXCIPIENT PERFORMANCE 赋形剂＜1061＞COLOR—INSTRUMENTAL MEASUREMENT显色－仪器(yíqì)测量＜1065＞Ion Chromatography 离子(lízǐ)色谱法＜1066＞PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE物理环境促使安全使用药物＜1072＞DISINFECTANTS AND ANTISEPTICS 消毒剂和防腐剂＜1074＞EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES赋形剂（辅料）生物安全性评估指导＜1078＞GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICALEXCIPIENTS批药品(yàopǐn)赋形剂的生产(shēngchǎn)管理规范＜1079＞Good Storage and Shipping Practices 良好(liánghǎo)的贮存与运输(yùnshū)规范(guīfàn)＜1080＞BULK PHARMACEUTICAL EXCIPIENTS—CERTIFICATE OF ANALYSIS 批药品赋形剂-COA＜1084＞GLYCOPROTEIN AND GLYCAN ANALYSIS—GENERAL CONSIDERATIONS糖蛋白和多糖分析-一般通则＜1086＞IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS药物和药物产品中的杂质＜1087＞APPARENT INTRINSIC DISSOLUTION—DISSOLUTION TESTING PROCEDURESFOR ROTATING DISK AND STATIONARYDISK内部的溶出度-旋转和静止溶出检测程序？＜1088＞IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS体内与体外的剂型的评估＜1090＞ASSESSMENT OF DRUG PRODUCTPERFORMANCE-BIOAVAILABILITY,BIOEQUIVALENCE, AND DISSOLUTION药物产品性能评估：生物利用(lìyòng)度、生物等效性和溶出＜1091＞LABELING OF INACTIVE INGREDIENTS 非活性成分(chéng fèn)的标示＜1092＞THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION溶出程序：开发(kāifā)与验证＜1094＞CAPSULES—DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES胶囊-关于(guānyú)产品质量的溶出测定＜1097＞BULK POWDER SAMPLING PROCEDURES：粉末(fěnmò)样品取样程序＜1102＞IMMUNOLOGICAL TEST METHODS—GENERAL CONSIDERATIONS免疫测试方法-总则＜1103＞IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENTASSAY (ELISA) 免疫学测试方法-酶联免疫吸附测定＜1104＞IMMUNOLOGICAL TEST METHODS—IMMUNOBLOT ANALYSIS免疫(miǎnyì)测试方法-免疫印迹法＜1105＞IMMUNOLOGICAL TEST METHODS—SURFACE PLASMON RESONANCE免疫测试方法-表面(biǎomiàn)等离子体共振＜1106＞IMMUNOGENICITY ASSAYS—DESIGN AND VALIDATION OF IMMUNOASSAYSTO DETECT ANTI-DRUG ANTIBODIES ？＜1111＞MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS:ACCEPTANCE CRITERIA FORPHARMACEUTICAL PREPARATIONSAND SUBSTANCES FORPHARMACEUTICAL USE非无菌产品的微生物学检查：药用制剂和制药过程(guòchéng)使用的物质接受标准＜1112＞MICROBIAL CHARACTERIZATION,IDENTIFICATION, AND STRAINTYPING非无菌药物产品(chǎnpǐn)水活性测定应用＜1113＞MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICALPRODUCTS非无菌药品(yàopǐn)中的微生物分布(fēnbù)＜1115＞BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS 非无菌药物和产品的生物负载(fùzài)控制＜1116＞MICROBIOLOGICAL CONTROL ANDMONITORING OF ASEPTICPROCESSING ENVIRONMENTS洁净的房间与其它(qítā)可控环境的微生物评估＜1117＞MICROBIOLOGICAL BESTLABORATORY PRACTICES 微生物最优实验室规范＜1118＞MONITORING DEVICES—TIME, TEMPERATURE, AND HUMIDITY监控装置－时间、温度与湿度＜1119＞NEAR-INFRARED SPECTROPHOTOMETRY近红外分光光度测定法＜1120＞Raman Spectrophotometry 拉曼分光光度测定法＜1121＞NOMENCLATURE命名＜1125＞NUCLEIC ACID-BASED TECHNIQUES—GENERAL 核酸技术(jìshù)-通则＜1126＞NUCLEIC ACID-BASED TECHNIQUES—EXTRACTION, DETECTION, AND SEQUENCING 核酸技术(jìshù)-提取、检测、测序＜1127＞NUCLEIC ACID-BASED TECHNIQUES—AMPLIFICATION 核酸(hé suān)技术-扩增＜1128＞NUCLEIC ACID-BASED TECHNIQUES—MICROARRAY 核酸(hé suān)技术-微阵列＜1129＞NUCLEIC ACID-BASED TECHNIQUES—GENOTYPING 核酸技术(jìshù)-基因分型＜1130＞NUCLEIC ACID-BASED TECHNIQUES—APPROACHES FOR DETECTING TRACENUCLEIC ACIDS (RESIDUAL DNATESTING)核酸技术-探测微量核酸的应用（残留DNA测试）＜1136＞PACKAGING AND REPACKAGING—SINGLE-UNIT CONTAINERS包装和再包装－单一容器＜1151＞PHARMACEUTICAL DOSAGE FORMS药物剂型＜1152＞ANIMAL DRUGS FOR USE IN ANIMAL FEEDS兽药在动物饲料(sìliào)中的使用＜1160＞PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING按处方混合的药物(yàowù)的计算＜1163＞QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING按处方(chǔfāng)混合的药物的质量保证＜1171＞PHASE-SOLUBILITY ANALYSIS相溶解(r óngjiě)分析＜1174＞Powder Flow 粉末(fěnmò)流动性＜1176＞PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS 处方天平与容量器具＜1177＞Good Packaging Practices 良好的包装操作＜1178＞Good Repackaging Practices 良好的再包装操作＜1180＞HUMAN PLASMA 人血浆＜1181＞SCANNING ELECTRON MICROSCOPY 扫描电子显微镜＜1184＞SENSITIZATION TESTING 致敏测试＜1191＞STABILITY CONSIDERATIONS IN DISPENSING PRACTICE分装操作中稳定性考察＜1195＞SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS散装药用辅料更换指导(zhǐdǎo)原则＜1197＞GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS散装药用辅料良好(liánghǎo)的分装操作＜1207＞STERILE PRODUCT PACKAGING—INTEGRITY EVALUATION无菌产品包装－完整性评估(pínɡɡū)＜1208＞STERILITY TESTING—VALIDATION OF ISOLATOR SYSTEMS无菌实验(shíyàn)－隔离系统的验证＜1209＞STERILIZATION—CHEMICAL ANDPHYSICOCHEMICAL INDICATORS ANDINTEGRATORS灭菌(miè jūn)－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 药典物品中的灭菌与灭菌保证＜1216＞TABLET FRIABILITY片剂的脆碎度＜1217＞TABLET BREAKING FORCE 片剂断裂力＜1222＞TERMINALLY STERILIZEDPHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE药品(yàopǐn)终端灭菌－放行(fàngxíng)参数(cānshù)＜1223＞VALIDATION OF ALTERNATIVEMICROBIOLOGICAL METHODS可供选择的微生物学方法(fāngfǎ)的验证＜1224＞TRANSFER OF ANALYTICALPROCEDURES 分析方法转移(zhuǎnyí)＜1225＞VALIDATION OF COMPENDIAL METHODS药典方法的验证＜1226＞VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认＜1227＞VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES 从药物中回收微生物的验证＜1229＞STERILIZATION OF COMPENDIAL ARTICLES 药典灭菌过程＜1229.1＞STEAM STERILIZATION BY DIRECT CONTACT 直接蒸汽灭菌＜1229.2＞MOIST HEAT STERILIZATION OF AQUEOUS LIQUIDS 水溶液的湿热灭菌＜1229.3＞MONITORING OF BIOBURDEN 生物(shēngwù)负载监控＜1229.4＞STERILIZING FILTRATION OF LIQUIDS 溶液(róngyè)的无菌过滤器＜1229.6＞LIQUID-PHASE STERILIZATION 液态(yètài)灭菌＜1229.7＞GASEOUS STERILIZATION 气态(qìtài)灭菌＜1229.8＞DRY HEAT STERILIZATION 干热(ɡàn rè)灭菌＜1229.10＞RADIATION STERILIZATION 辐射灭菌＜1230＞WATER FOR HEMODIALYSIS APPLICATIONS 血液透析过程用水＜1231＞WATER FOR PHARMACEUTICAL PURPOSES制药用水＜1234＞VACCINES FOR HUMAN USE—POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES人用疫苗-多糖和糖复合物疫苗＜1235＞VACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS 人用疫苗-通则＜1237＞VIROLOGY TEST METHODS 病毒测试方法＜1238＞VACCINES FOR HUMAN USE—BACTERIAL VACCINES 人用疫苗-细菌疫苗＜1240＞VIRUS TESTING OF HUMAN PLASMA FOR FURTHER MANUFACTURE下一步使用(shǐyòng)人血浆的病毒测试＜1241＞WATER–SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS在药物(yàowù)系统中水与固体的相互作用＜1251＞WEIGHING ON AN ANALYTICAL BALANCE关于分析天平(fēn xī tiān pínɡ)的称重＜1265＞Written Prescription Drug Information－Guidelines 书面(shūmiàn)的处方药信息－指南＜1285＞PREPARATION OF BIOLOGICALSPECIMENS FOR HISTOLOGIC ANDIMMUNOHISTOCHEMICAL ANALYSIS 为了(wèi le)组织和免疫组织分析的生物标本制备＜1285.1＞HEMATOXYLIN AND EOSIN STAINING OF SECTIONED TISSUE FORMICROSCOPIC EXAMINATION显微镜观察用苏木精和伊红染色的切片＜1601＞PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS 产品雾化状态-性状描述＜1644＞THEORY AND PRACTICE OFELECTRICAL CONDUCTIVITYMEASUREMENTS OF SOLUTIONS 溶液电导(diàn dǎo)值测量方法的理论与实践＜1660＞EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS 玻璃(bō lí)容器内表面耐久性评估＜1724＞SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS 半固态药物(yàowù)产品-性能测试＜1736＞APPLICATIONS OF MASSSPECTROMETRY 质谱应用(yìngyòng)＜1761＞APPLICATIONS OF NUCLEARMAGNETIC RESONANCESPECTROSCOPY核磁共振(hé cíɡònɡ zhèn)光谱应用＜1787＞MEASUREMENT OF SUBVISIBLEPARTICULATE MATTER INTHERAPEUTIC PROTEIN INJECTIONS 用显微镜测量方法测量治疗性蛋白注射剂的不溶性微粒＜1788＞METHODS FOR THE DETERMINATION OF PARTICULATE MATTER ININJECTIONS AND OPHTHALMICSOLUTIONS注射剂和眼用溶液的不溶性微粒测定(cèdìng)的方法选择＜1852＞ATOMIC ABSORPTION SPECTROSCOPY—THEORY AND PRACTICE原子吸收光谱(xī shōu ɡuānɡ pǔ)-理论与实践＜1853＞FLUORESCENCE SPECTROSCOPY—THEORY AND PRACTICE荧光光谱-理论(lǐlùn)与实践＜1854＞MID-INFRARED SPECTROSCOPY—THEORY AND PRACTICE中红外光谱(guāngpǔ)-理论与实践＜1857＞ULTRAVIOLET-VISIBLESPECTROSCOPY—THEORY ANDPRACTICE紫外可见(kějiàn)光谱-理论与实践＜1911＞RHEOMETRY 流变测定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(yíngy ǎng)与食品添加剂＜2022＞MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS (3083)不得(bu de)检出特定微生物的程序－营养与营养(yíngy ǎng)补充剂＜2023>MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS……3087非无菌的营养与食品(shípǐn)添加剂中的微生物分布<2040>DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS (3089)食品(shípǐn)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内容总结（1）USP38-通用章节目录。
N-乙酰氨基葡糖
N-乙酰氨基葡萄糖中文名称：N-乙酰氨基葡萄糖中文别名： N-乙酰-D-氨基葡萄糖; 2-(乙酰基氨基)-2-脱氧-D-葡萄糖; N-乙酰葡萄糖胺; N-乙酰-D-葡糖胺; N-乙酰-D-葡萄糖胺; N-乙酰氨基-2-脱氧-D-葡糖; N-乙酰胺基-2-脱氧-D-葡糖; N-乙醯葡萄胺糖英文名称：N-acetyl-D-(+)-glucosamine英文别名： n-acetyl-beta-d-glucosamine; n-acetyl-d-glucosamine; 2-acetamido-2-deoxy-d-glucopyranose;N-((1R,2R,3S,4R)-1-FORMYL-2,3,4,5-TETRAHYDROXY-PENTYL)-ACETAMIDE;N-ACETYL-D-GLUCOSAMINE, IMMOBILIZED ON DIVINYLSULFONE-ACTIVATED AGAROSE 6B; N-ACETYL-D-GLUCOSAMINIDE; N-ACETYLGLUCOSAMINE;ACETYL-D-GLUCOSAMINE, N-; 2-ACETAMIDO-2-DEOXY-D-GLUCOSE;2-(acetylamino)-2-deoxy-d-glucos;2-ACETAMIDO-2-DESOXY-D-GLUCOPYRANOSE; 2-ACETAMIDO-2-DEOXY GLUCOPYRANOSE; D-GLCNAC; N-ACETYL-L-GLUCOSAMINE;N-[2,4,5-TRIHYDROXY-6-(HYDROXYMETHYL)TETRAHYDRO-2H-PYRAN-3-YL]ACET AMIDECAS RN：134451-94-8[1]EINECS：231-368-2分子式：C8H15NO6分子量：221.21物理化学性质：熔点 201-204°C比旋光度42° (c=2,water,2 hrs)产品用途用作骨关节炎、风湿性关节炎治疗剂，食品添加剂生化反应1876年德国外科医师兼药剂学家格奥尔格·莱德豪斯（Georg Ledderhose）第一个从甲壳素的水解产物中分离出氨基葡萄糖，但是直到1939年诺贝尔化学奖得主沃尔特·霍沃思才确定氨基葡萄糖的立体结构[1]。
n-乙酰氨基葡萄糖质量标准
n-乙酰氨基葡萄糖质量标准n-乙酰氨基葡萄糖是一种重要的有机化合物，常用作食品和药物添加剂。
它具有许多生物活性和药理活性，因此其质量标准非常重要。
下面将对n-乙酰氨基葡萄糖的质量标准进行详细介绍。
首先，n-乙酰氨基葡萄糖的外观要求应为白色结晶性粉末，并且不应有杂质存在。
这是基本的外观质量要求，确保产品的纯度和可用性。
其次，n-乙酰氨基葡萄糖的化学性质也应符合一定的标准。
它的化学式为C8H15NO6，分子量为221.21。
在质量标准中，可以规定其含量、比旋光度、水分含量、溶解度等重要化学性质。
例如，n-乙酰氨基葡萄糖的含量可以通过高效液相色谱法进行测定，以确保产品中有效成分的含量符合要求。
水分含量则可以通过烘干法进行测试，确保产品中的水分不超过一定的限制。
此外，溶解度是衡量产品溶解性的重要指标，可以通过溶解度试验进行测定。
同时，n-乙酰氨基葡萄糖作为药物添加剂，其微生物质量也是非常重要的。
在质量标准中，可以规定其菌落总数、大肠杆菌、酵母和霉菌等微生物指标。
这些指标可以通过菌落总数试验、大肠杆菌试验、酵母和霉菌试验等常规微生物检验方法进行测定。
如果微生物质量不合格，将对产品的质量和安全性造成严重影响。
此外，n-乙酰氨基葡萄糖的重金属含量也是质量标准中需要考虑的因素之一。
重金属如铅、汞、砷等具有潜在的毒性，对人体健康造成危害。
因此，在质量标准中可以规定n-乙酰氨基葡萄糖中重金属含量的上限，以确保产品的安全性。
最后，n-乙酰氨基葡萄糖作为食品和药物添加剂，其质量标准还应包括一些特殊要求。
例如，对于食品添加剂，应考虑其功能性和适用范围；对于药物添加剂，应考虑其纯度、稳定性、溶出度等药理学特性。
此外，还需要考虑n-乙酰氨基葡萄糖的包装和储存条件等因素，以保证产品在使用期限内保持稳定性和活性。
总之，n-乙酰氨基葡萄糖的质量标准是确保其用途和安全性的关键因素。
通过规定其外观、化学性质、微生物质量、重金属含量等多个指标，可以有效控制产品的质量，提高其可用性和安全性。
HPLC法测定硫酸氨基葡萄糖相关物质N_乙酰氨基葡萄糖_华阳
北方药学2014年第11卷第5期ＨＰＬＣ法测定硫酸氨基葡萄糖相关物质Ｎ－乙酰氨基葡萄糖华阳１杨宗凡２（１．江苏省南通市海安县人民医院海安２２６６００；２．中国药科大学生命科学与技术学院南京２１１１９８）摘要：目的：建立硫酸氨基葡萄糖相关物质N-乙酰氨基葡萄糖检测的HPLC法。
方法：流动相为0.006mol/L H2SO4；色谱柱为Shodex Suger SH1011（300mm×8mm）；流速：0.6ml/min；柱温：50℃；检测波长：202nm。
结果：N-乙酰氨基葡萄糖的线性范围为0.0001～0.02mg/ml，相关系数为0.998，平均回收率为99.05%，RSD为1.32%。
结论：本方法专属性好、准确度高，适用于硫酸氨基葡萄糖相关物质N-乙酰氨基葡萄糖检测。
关键词：HPLC N-乙酰氨基葡萄糖硫酸氨基葡萄糖中图分类号：Ｒ９２７．２文献标识码：Ａ文章编号：１６７２－８３５１（２０１４）０５－００１９－０１硫酸氨基葡萄糖为天然的氨基单糖，是人体关节软骨基质中合成蛋白聚糖必需成分。
氨基单糖可刺激软骨细胞产生具有正常多聚体结构的糖蛋白，抑制某些可损害关节软骨的酶，抑制损伤细胞的超氧化物自由基的产生，防止皮质激素及某些非甾体类抗炎药对软骨细胞的损害，减少损伤细胞的内毒素因子的释放，目前其主要用于治疗和预防骨性关节炎以及食品添加剂[1]。
在生产过程中，由于N-乙酰氨基葡萄糖的溶解性质与氨基葡萄糖相似，故重结晶时常会出现少量N-乙酰氨基葡萄糖的残留[2]，为了有效控制硫酸氨基葡萄糖生产及贮存过程中产生的N-乙酰氨基葡萄糖，本研究建立了硫酸氨基葡萄糖相关物质N-乙酰氨基葡萄糖的HPLC测定法，现报道如下。
1仪器与试剂Shimadzu LC-20A高效液相色谱仪（日本岛津制作所），包括LC-20AD泵，SIL-20A自动进样器，SPD-10A紫外检测器，岛津LC-solution色谱数据工作站。
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USP 38Dietary Supplements / N-Acetylglucosamine5865 Dietary SupplementsOfficial Monographs[N OTE—The relative retention times for N-acetyl-glucosamine and glucosamine are 1.0 and about 2.8, N-Acetylglucosaminerespectively.]Suitability requirementsSignal-to-noise ratio: NLT 10 for the glucosaminepeak, System suitability solutionResolution: NLT 5.0 between the N-acetyl-glucosamine and glucosamine peaks, System suitabil-ity solutionTailing factor: NMT 2.0, Standard solutionRelative standard deviation: NMT 2.0%, StandardsolutionC8H15NO6221.21Analysis2-(Acetylamino)-2-deoxy-D-glucose;Samples:Standard solution and Sample solutionN-Acetyl-D-Glucosamine [7512-17-6].Calculate the percentage of N-acetylglucosamine(C8H15NO6) in the portion of N-Acetylglucosamine DEFINITION taken:N-Acetylglucosamine contains NLT 98.0% and NMT 102.0%of N-acetylglucosamine (C8H15NO6), calculated on the Result = (rU/r S) × (C S/C U) × 100dried basis.r U= peak response from the Sample solution IDENTIFICATION rS= peak response from the Standard solution •A. I NFRARED A BSORPTION〈197K〉CS= concentration of USP N-Acetylglucosamine RS •B. It meets the requirements in the test for Optical Rota-in the Standard solution (mg/mL) tion 〈781S〉, Specific Rotation.CU= concentration of N-Acetylglucosamine in the •C. The retention time of the major peak of the Sample Sample solution (mg/mL) solution corresponds to that of the Standard solution, as Acceptance criteria: 98.0%–102.0% on the dried basis obtained in the Assay.IMPURITIESASSAY•R ESIDUE ON I GNITION〈281〉: NMT 0.1%•P ROCEDURE•C HLORIDE AND S ULFATE, Chloride〈221〉: NMT 0.1% Buffer: Transfer 3.5g of dibasic potassium phosphate to•E LEMENTAL I MPURITIES—P ROCEDURES〈233〉a 1-L volumetric flask, and add sufficient water to dis-Acceptance criteriasolve. Add 0.25mL of ammonium hydroxide, dilute Arsenic: NMT 1µg/gwith water to volume, and mix. Adjust with phosphoric Lead: NMT 10µg/gacid to a pH of 7.5.•R ELATED C OMPOUNDSMobile phase: Acetonitrile and Buffer (75:25)Buffer, Mobile phase, Diluent, System suitability solu-Diluent: Acetonitrile and water (50:50)tion, Chromatographic system, and System suitabil-System suitability solution: 1.0mg/mL of USP N-ity: Proceed as directed in the Assay.Acetylglucosamine RS and 0.6mg/mL of USP Glucosa-Sample solution: 2.5mg/mL of N-Acetylglucosamine in mine Hydrochloride RS in Diluent DiluentStandard solution: 1.0mg/mL of USP N-Acetyl-Analysisglucosamine RS in Diluent Sample:Sample solutionSample solution: 1.0mg/mL of N-Acetylglucosamine in Calculate the percentage of each impurity in the por-Diluent tion of N-Acetylglucosamine taken:Chromatographic system(See Chromatography 〈621〉, System Suitability.)Result = (rU/r T) × 100 Mode: LCDetector: UV 195 nm r U= peak response of each impurity from the Column: 4.6-mm × 15-cm; 3-µm packing L8Sample solutionColumn temperature: 35°r T= sum of the peak responses from the Sample Flow rate: 1.5mL/min solutionInjection volume: 10µLSystem suitabilitySamples:System suitability solution and Standardsolution5866N -Acetylglucosamine / Dietary SupplementsUSP 38Acceptance criteriaDEFINITIONIndividual impurity: NMT 0.5% N -Acetyltyrosine contains NLT 98.5% and NMT 101.0% of Total impurities: NMT 2.0%N -acetyltyrosine (C 11H 13NO 4), as N -acetyl-L -tyrosine, calcu-•L IMIT OF G LUCOSAMINElated on the dried basis.Buffer, Mobile phase, Diluent, System suitability solu-IDENTIFICATIONtion, Chromatographic system, and System suitabil-•A . I NFRARED A BSORPTION 〈197K 〉ity: Proceed as directed in the Assay .•B . O PTICAL R OTATION , Specific Rotation 〈781S 〉Standard solution: 0.6mg/mL of USP Glucosamine Hy-Sample solution: 10mg/mLdrochloride RS in DiluentAcceptance criteria: NLT +46.0° and NMT +49.0°, de-Sample solution: 50mg/mL of N -Acetylglucosamine in termined at 20°Diluent •C . The R F value of the principal spot of the Sample solu-Analysistion in the test for Organic Impurities corresponds to that Samples: Standard solution and Sample solutionof Standard solution 1.Calculate the percentage of glucosamine in the portion of N -Acetylglucosamine taken:ASSAY•P ROCEDUREResult = (r U /r S ) × (C S /C U ) × (M 1/M 2) × 100Sample solution: Dissolve about 180mg of N -Acetyltyrosine, weighed, in 50mL of carbon dioxide-r U= peak response of glucosamine from thefree water.Sample solutionTitrimetric system r S = peak response of glucosamine from the(See Titrimetry 〈541〉.)Standard solutionMode: Direct titrationC S = concentration of USP GlucosamineTitrant: 0.1 N sodium hydroxide VS Hydrochloride RS in the Standard solution Endpoint detection: Potentiometric(mg/mL)Equivalency: Each mL of 0.1 N sodium hydroxide VS C U = concentration of N -Acetylglucosamine in theis equivalent to 22.32mg of N -acetyltyrosine Sample solution (mg/mL)(C 11H 13NO 4).M 1= molecular weight of glucosamine, 179.17M 2= molecular weight of glucosamineIMPURITIEShydrochloride, 215.63•R ESIDUE ON I GNITION 〈281〉: NMT 0.1%Acceptance criteria: NMT 1.0%•C HLORIDE AND S ULFATE , Chloride 〈221〉Sample: 0.7gSPECIFIC TESTSStandard: 0.40mL of 0.01 N hydrochloric acid •O PTICAL R OTATION , Specific Rotation 〈781S 〉Acceptance criteria: NMT 200ppm Sample solution: 20mg/mL in water, perform the •C HLORIDE AND S ULFATE , Sulfate 〈221〉measurement 3 h after sample preparation.Sample: 1.2gAcceptance criteria: +39.0° to +43.0°Standard: 0.25mL of 0.020 N sulfuric acid •P H 〈791〉Acceptance criteria: NMT 200ppm Sample solution: 10mg/mL in water •I RON 〈241〉: NMT 20ppmAcceptance criteria: 6.0–8.0•L OSS ON D RYING 〈731〉Analysis: Dry a sample at 105° for 2 h.Delete the following:Acceptance criteria: NMT 0.5%•M ELTING R ANGE OR T EMPERATURE 〈741〉: 196°–205°••H EAVY M ETALS , Method 1 〈231〉: NMT 10ppm •(Official 1-•M ICROBIAL E NUMERATION T ESTS 〈2021〉: The total aerobic Dec-2015)bacterial count does not exceed 103 cfu/g; the total com-•O RGANIC I MPURITIESbined molds and yeasts count does not exceed 103 cfu/Adsorbent: 0.25-mm layer of chromatographic silica g.gel mixture•A BSENCE OF S PECIFIED M ICROORGANISMS 〈2022〉: Meets the Standard stock solution 1: 8mg/mL of USP N -Acetyl-L -requirements of the tests for absence of Salmonella spe-tyrosine RS in a mixture of water, glacial acetic acid,cies and Escherichia coliand alcohol (3:3:94)Standard solution 1: Dilute Standard stock solution 1ADDITIONAL REQUIREMENTSwith alcohol to obtain a solution having a known con-•P ACKAGING AND S TORAGE : Preserve in tight, light-resistant centration of about 0.4mg/mL.containers.Standard solution 2: 0.8mg/mL of USP L -Tyrosine RS •USP R EFERENCE S TANDARDS 〈11〉dissolved in a mixture of glacial acetic acid and water USP N -Acetylglucosamine RS(1:1), and diluted with alcoholUSP Glucosamine Hydrochloride RSSample solution: Transfer 0.8g of N -Acetyltyrosine to a 10-mL volumetric flask, dissolve in 6mL of a mixture of glacial acetic acid and water (1:1), and dilute with alco-hol to volume.Application volume: 5µLN -AcetyltyrosineDeveloping solvent system: A mixture of ammonia and 2-propanol (3:7)Spray reagent: Dissolve 0.2g of ninhydrin in 100mL of a mixture of butanol and 2N acetic acid (95:5).Analysis: Proceed as directed for Chromatography 〈621〉,Thin-Layer Chromatography. After air-drying the plate,repeat the development process. After air-drying a sec-ond time, examine the plate under short-wave UV light,C 11H 13NO 4223.2and record principal and secondary spots. Spray the N -Acetyl-L -tyrosine;plate with Spray reagent , and heat between 100° and (2S )-2-(Acetylamino)-3-(4-hydroxyphenyl)propanoic acid)105° for about 15 min. Examine the plate under white [537-55-3].light, and record the principal and secondary spots.。