USP美国药典代码
美国药典简介
美国药典简介1. 标题和修订（Title and Revision）. 92. 药典地位和法律认可（Official status and legal recognition）92.10 药典正文(Official Text) 92.20 药典物品（Official Articles）. 92.30 法律认可（Legal Recognition）. 103. 与标准的符合性（Conformance to standard）. 103.10 标准的适用性(Applicability of standard) 103.10.10 制剂、原料药、辅料的标准的适用性（Applicability of Standards to Drug Products, Drug Substances, and Excipients）. 103.10.20 医疗器械、营养补充剂、以及其组成成分的标准的适用性（Applicability of Standards to Medical Devices, Dietary Supplements, and Their Components and Ingredients）113.20 一致性的标示（Indicating Conformance）. 114. 药典各论和通则（Monographs and general chapters）124.10 各论(Monographs) 124.10.10 检测程序的适用性(Applicability of Test Procedures) 124.10.20 接受标准(Acceptance Criteria) 124.20 附录（General Chapter）. 125. 各论组成（Monograph Components）. 135.10 分子式（Molecular formula）. 135.20 附加物质、赋形剂、组分(Added Substances, Excipients, and Ingredients) 135.20.10官方原料药中附加的物质、赋形剂、组分（Added Substances, Excipients, and Ingredien ts in Official Substances）. 135.20.20官方制剂中的附加物质、赋形剂、组分（Added Substances, Excipients, and Ingredients in Official Products）. 135.30 性状和溶解性（Description and Solubility）. 145.40 鉴定试验（Identification Test）. 145.50 含量分析（Assay）. 155.50.10 效价单位（生物效价）(Units of Potency (Biological)) 155.60 杂质和外来物质（Impurities and Foreign Substances）. 155.60.10 USP和NF物品的其它杂质（Other Impurities in USP and NF Articles）155.60.20 USP和NF物品中的残留溶剂（Residual Solvents in USP and NF Articles）165.70性能检测（Performance Tests）. 165.80 USP标准品（Residual Solvents in USP and NF Articles）. 166. 检验规范和分析方法（Testing practices and procedures）166.10 安全的实验室规范（Safe Laboratory Practices）. 166.20 自动化程序（Automated Procedures）. 166.30 可选择的和谐的方法与程序（Alternative and Harmonized Methods and Procedures）166.40 干燥的、无水的、灼烧的、无溶剂的（Dried, Anhydrous, Ignited, or Solvent-Free Basis）176.40.10 灼烧至恒重（Ignite To Constant Weight）. 176.40.20 干燥至恒重（Dried To Constant Weight）. 176.50 溶液的制备（Preparation of Solutions）. 186.50.10 过滤（Filtration）. 186.50.20 溶液（Solutions）. 186.60 完成一个实验所需多少单位（Units Necessary to Complete a Test）. 186.60.10 片剂（Tablets）. 186.60.20 胶囊（Capsules）. 196.70 试剂（Reagents）. 196.80 设备（Equipment）. 196.80.10 测量仪器（Apparatus for Measurement）. 196.80.20 仪器设备（Instrumental Apparatus）. 197. 测试结果（Test Results）. 207.10 质量要求的解释(Interpretation of Requirements) 207.10.10 滴定程序中的等效表述(Equivalence Statements in Titrimetric Procedures) 207.20 修约原则(Rounding Rules) 208. 术语和定义(Terms and Definitions) 218.10 缩写(Abbreviations) 218.20 大约(About) 218.30 乙醇含量(Alcohol Content) 218.40 原子量(Atomic Weights) 228.50 空白试验(Blank Determinations) 228.60伴随(Concomitantly) 228.70 干燥器(Desiccator) 228.80 对数（Logarithms）. 228.90 微生物菌株(Microbial Strain) 228.100 可忽略的（Negligible）. 228.110 NLT/NMT 228.120 气味(Odor) 228.130 百分比(Percent) 228.140 百分比浓度(Percentage Concentrations) 238.150 压力(Pressure) 238.160 反应时间(Reaction Time) 238.170 比重(Specific Gravity) 238.180 温度(Temperatures) 238.190 时间(Time) 238.200 转移（Transfer）. 238.210 真空（Vacuum）. 238.220 真空干燥器（Vacuum Desiccator）. 238.230 水（Water）. 248.230.10 水作为官方制剂中的组分（Water as an Ingredient in an Official Product）24 8.230.20 水用于官方原料药的生产（Water in the Manufacture of Official Substances）24 8.230.30 药典实验操作用水（Water in a Compendial Procedure）. 248.240 称量和测量（Weights and Measures）. 249. 开处方和配药（Prescribing and Dispending）. 259.10 公制单位的使用（Use of Metric Units）. 259.20 体积的改变（Changes in Volume）. 2510. 保存、包装、储存、贴签（preservation，packaging，storage and labeling）2510.10 在非特定条件下储存（Storage Under Nonspecific Conditions）. 2510.20 包装容器（Containers）. 2510.20.10显窃启包装（Tamper-Evident Packaging）. 2610.20.20 避光容器（Light-Resistant Container）. 2610.20.30密闭良好的容器（Well-Closed Container）. 2610.20.40密封的容器（Tight Container）. 2610.20.50严封的容器（Hermetic Container）. 2710.20.60单元包装（Single-Unit Container）. 2710.20.70单剂量包装（Single-Dose Container）. 2710.20.80单元剂量容器（Unit-Dose Container）. 2710.20.90单元使用的容器（Unit-of-Use Container）. 2710.20.100多单元容器（Multiple-Unit Container）. 2710.20.110多剂量容器（Multiple-Dose Container）. 2710.20.120毒物保护包装法案（Requirements under the Poison Prevention Packaging Act (PPPA)）2710.30 储存温度和湿度（Storage Temperature and Humidity）. 2810.30.10 冷冻（Freezer）. 2810.30.20冷处（Cold）. 2810.30.30 凉处（Cool）. 2810.30.40 可控的凉爽温度（controlled cold temperature）. 2810.30.50 室温（room temperature）. 2910.30.60 可控的室温（Controlled Room Temperature）. 2910.30.70 温暖（warm）. 2910.30.80 过热（Excessive Heat）. 2910.30.90 防冻（Protection From Freezing）. 2910.30.100 干燥处（Dry Place）. 2910.40 标签（Labeling）. 2910.40.10每个剂量单元中组分的量（Amount of Ingredient Per Dosage Unit）3010.40.20 首位和末位零的使用（Use of Leading and Terminal Zeros）. 3010.40.30药品中盐的标示（Labeling of Salts of Drugs）. 3010.40.40含维生素产品的标示（Labeling Vitamin-Containing Products）. 3010.40.50含植物药材的产品的标示（Labeling Botanical-Containing Products）3110.40.60非肠道和局部制剂的标示（Labeling Parenteral And Topical Preparations）3110.40.70电解液的标示（Labeling Electrolytes）. 3110.40.80乙醇的标示（Labeling Alcohol）. 3110.40.90特殊的胶囊和片剂（Special Capsules and Tablets）. 3110.40.100有效期和失效期（expiration date and beyond-use date）. 3110.50 USP-NF药典正文中关于包装和储存的指南（Guidelines for Packaging and Storage State ments in USP–NF Monographs）. 32General Notices and Requirements(凡例和要求)Change to read:凡例部分为药典的解释和应用提出了基本的假定、定义、默认条件。
美国药典USP-1478549奥美拉唑镁的msds
Material Safety Data Sheet USP Reference Standards are sold for chemical test and assay purposes only, and NOT for human consumption. The information contained herein is applicable solely to the chemical substance when used as a USP Reference Standard and does not necessarily relate to any other use of the substance described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP Reference Standards are intended for use by persons having technical skill and at their own discretion and risk. This information has been developed by USP staff from sources considered reliable but has not beenindependently verified by the USP. Therefore, the USP Convention cannot guarantee the accuracy of the information in these sources nor should the statements contained herein be considered an official expression. NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information contained herein.ATTENTION !12601 Twinbrook Parkway, Rockville, MD 20852 USA Phone Calls:301-816-81298 a.m. to 5 p.m. EST Mon. - Fri.OMEPRAZOLE MAGNESIUM Catalog Number:1478549Revision Date:March 20, 2007SECTION 2 - HAZARD INFORMATIONCommon Name:Omeprazole Magnesium SECTION 1 - PRODUCT AND COMPANY IDENTIFICATIONSECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTSEMERGENCY OVERVIEW - Allergen.Adverse Effects:Adverse effects of omeprazole may include cough; nasal or ear congestion; chills, fever, or sore throat; loss of voice;runny nose; difficulty breathing; body aches or pains; heart burn, diarrhea, gas, skin rash or itching, unusual tiredness,dizziness, constipation, headache, and nausea or vomiting. Possible allergic reaction to material if inhaled, ingestedor in contact with skin.Overdose Effects:Symptoms of omeprazole overdose may include blurred vision, confusion, increased sweating, drowsiness, drymouth, flushing, headache, severe stomach pain, nausea or vomiting, and fast or irregular heartbeat.Acute:Possible eye, skin, gastrointestinal and/or respiratory tract irritation.Chronic:Possible hypersensitization.Medical Conditions Aggravated by Exposure:Hypersensitivity to the material and chronic liver disease (current or history of).Cross Sensitivity:n/fTarget Organs:Gastrointestinal tractFor additional information on toxicity, see Section 11.Common Name:Omeprazole MagnesiumFormula:C34H36MgN6O6S2Manufacturer:U. S. PharmacopeiaResponsible Party:Reference Standards Technical ServicesMailing Address:12601 Twinbrook Parkway, Rockville, MD 20852 USAPhone:301-816-8129Hours:8 a.m. to 5 p.m. EST Mon. - Fri.Product Use:USP Reference Standards and Authentic Substances are used for chemical tests and assays in analytical,clinical, pharmaceutical, and research laboratories.Synonym:n/fChemical Name:5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, magnesium salt (2:1) CAS:95382-33-5RTECS Number:n/fChemical Family:Substituted benzimidazoleTherapeutic Category:Gastric acid secretory depressantComposition:Pure MaterialSECTION 4 - FIRST AID MEASURESInhalation:May cause irritation. Avoid inhalation. Remove to fresh air.Eye:May cause irritation. Avoid contact. Flush with copious quantities of water for at least 15 minutes.Skin:May cause irritation and sensitization. Avoid contact. Flush with copious quantities of soap and water.Ingestion:May cause irritation. Flush out mouth with water.General First Aid Procedures:Remove from exposure. Remove contaminated clothing. Persons developing serious hypersensitivity(anaphylactic) reactions must receive immediate medical attention. If person is not breathing giveartificial respiration. If breathing is difficult give oxygen. Obtain medical attention.Note to PhysiciansOverdose Treatment:Treatment of omeprazole overdose should be symptomatic and supportive and may include the following:1. Administer activated charcoal as a slurry.2. Sinus tachydysrhythmias do not need to be routinely treated unless patient is hemodynamically unstable.3. Omeprazole is not readily dialyzable. [Meditext 2007 & USP DI 2007]SECTION 5 - FIREFIGHTING MEASURESExtinguisher Media:Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.Fire and Explosion Hazards:This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.Firefighting Procedures:As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathingequipment and protective clothing.SECTION 6 - ACCIDENTAL RELEASE MEASURESSpill Response:Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeledcontainer for disposal. Wash spill site.SECTION 7 - HANDLING AND STORAGEHandling:As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.Storage:Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. Store in a refrigerator.SECTION 8 - EXPOSURE CONTROL / PERSONAL PROTECTIONEngineering Controls:Engineering controls such as exhaust ventilation are recommended.Respiratory Protection:Use a NIOSH-approved respirator, if it is determined to be necessary by an industrial hygiene surveyinvolving air monitoring. In the event that a respirator is not required, an approved dust mask should be used. Gloves:Chemically compatibleEye Protection:Safety glasses or gogglesProtective Clothing:Protect exposed skin.Exposure Limits:Industry: 0.5 mg/m3 (omeprazole)SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIESProperties as indicated on the MSDS are general and not necessarily specific to the USP Reference Standard Lot provided. Appearance and Odor:White to almost white crystalline powderOdor Threshold:n/fpH:Approximately 10.5 (aqueous suspension)Melting Range:n/fBoiling Point:n/fFlash Point:n/fAutoignition Temperature:n/fEvaporation Rate:n/fUpper Flammability Limit:n/fLower Flammability Limit:n/fVapor Pressure:n/fVapor Density:n/fSpecific Gravity:n/fSolubility in Water:Very slightly solubleFat Solubility:n/fOther Solubility:Soluble in methanolPartition Coefficient: n-octanol/water:n/fPercent Volatile:n/fReactivity in Water:n/fExplosive Properties:n/fOxidizing Properties:n/fFormula:C34H36MgN6O6S2Molecular Weight:713.12Oral Rat:LD50: >2000 mg/kgOral Mouse:n/fNTP:No IARC:No OSHA:NoListed as a Carcinogen by: Irritancy Data:n/f SECTION 11 - TOXICOLOGICAL PROPERTIESOther Toxicity Data:n/fCorrosivity:n/f Sensitization Data:Omeprazole is a strong sensitizer in guinea pigs. (Guinea pig maximization test)Other Carcinogenicity Data:No evidence of carcinogenicity was found in mice orally administered up to 140 mg/kg/day omeprazolefor 66 weeks. In two 2-year studies in rats, omeprazole given in doses up to 140.8 mg/kg/day causedgastric carcinoid tumors and enterochromaffin-like (ECL) cell hyperplasia in a dose-dependent manner in both males and females.Mutagenicity Data:Omeprazole produced clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, in oneof two in vivo mouse micronucleus tests, and in an in vivo bone marrow cell chromosomal aberration assay. Omeprazole was negative in the in vitro Ames Salmonella typhimurium assay, an in vitro mouse lymphoma cell forward mutation assay, and an in vivo rat liver DNA damage assay.Reproductive and Developmental Effects:Sporadic instances of developmental abnormalities in infants born to women who receivedomeprazole during pregnancy have been reported. Epidemiological studies have not foundan association between the use of omeprazole during pregnancy and an increased risk ofbirth defects.Omeprazole did not impair fertility in rats at parenteral doses of up to 138 mg/kg/day. Nobirth defects were seen in pregnant rabbits and rats administered omeprazole in doses up to69 mg/kg/day and 138 mg/kg/day, respectively.In rabbits, 6.9 - 69.1 mg/kg/day omeprazole produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruption. In rats, dose-related embryo/fetaltoxicity and post natal developmental toxicity were observed in the rat offspring of parentstreated with 13.8 - 138 mg/kg/day.SECTION 12 - ECOLOGICAL INFORMATIONEcological Information:Omeprazole sodium, a related compound, may cause long-term adverse effects in the aquatic environment andis not readily biodegradable.SECTION 13 - DISPOSAL CONSIDERATIONSDisposal:Dispose of waste in accordance with all applicable Federal, State and local laws.SECTION 14 -TRANSPORT INFORMATIONShipping Name:n/fClass:n/f Stable?Yes Conditions to Avoid:Avoid exposure to light.Incompatibilities:n/fDecomposition Products:When heated to decomposition material emits toxic fumes of SOx and NOx. Emits toxic fumes under fireconditions.Hazardous Polymerization?No SECTION 10 - STABILITY AND REACTIVITYUN Number:n/fPacking Group:n/fAdditional Transport Information:n/fSECTION 15 - REGULATORY INFORMATION U.S. Regulatory Information:n/fInternational Regulatory Information:Risk Phrases: R43, R52/53Safety Phrases: S37, S61SECTION 16 - OTHER INFORMATIONRevision:20-Mar-07Previous Revision Date:05-Feb-07。
常用制药及GMP英文缩写
常用制药及GMP英文缩写第一篇：常用制药及GMP英文缩写ISO（International Organization for Standardization）：国际标准化组织日常办事机构是中央秘书处，设在瑞士日内瓦WHO（World Health Organization）：世界卫生组织是联合国属下的专门机构，国际最大的公共卫生组织，总部设于瑞士日内瓦PIC/S（Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme）：国际医药品稽查协约组织由欧洲自由贸易区（EFTA）组建ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use）：人用药物注册技术要求国际协调会由欧盟（EU）、欧洲制药工业协会联合会（EFPIA）、日本厚生省（MHW）、日本制药工业协会（JPMA）、美国FDA、美国药物研究生产联合会（PRMA）等机构组成WHO、EFTA、加拿大卫生保健局（CHPB）为观察员ISPE（International Society for Pharmaceutical Engineering）：国际制药工程协会是致力于培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一，在美国坦帕州设有全球总部，在布鲁塞尔设有欧洲总部，亚洲总部在新加坡HHS（United States Department of Health and Human Services）：美国卫生及公共服务部（美国卫生部）FDA（Food and Drug Administration）：美国食品药品监督管理局（HHS下属机构）PDA（Parenteral Drug Association）：美国注射剂协会EPA （Environmental Protection Agency）：美国国家环境保护局CDER（Center for Drug Evaluation and Research）：FDA药物评价与研究中心EMEA（The European Agency for the Evaluation of Medicinal Products）：欧洲药物评审组织MHW（Ministry of Health and Welfare）：日本厚生省，现改为厚生劳动省MHLW（Ministry of Health, Labor and Welfare），负责医疗卫生和社会保障的主要部门 D&B（Dun & Bradstreet）：邓白氏公司DUNS（DataUniversal Numbering System）：邓白氏公司提供的唯一的公司代号，用于信用评级等在SMF文件中会用到GMP（Good Manufacturing Practice）：药品良好生产规范cGMP（Current Good Manufacture Practices）：动态药品生产管理规范，即现行的GLP（Good Laboratory Practice）：药物非临床研究质量管理规范，及优良实验室规范GSP（Good Supplying Practice）：药品经营质量管理规范，及良好的药品供应规范GAP（Good Agricultural Practice for Chinese Crude Drugs）：中药材生产质量管理规范GDP（Good Documentation Practice）：良好文件管理GEP （Good Engineering Practice）：工程设计规范GAMP（Good Automated Manufacturing Practice）：优良自动化生产规范USP（united states pharmacopeia）：美国药典EP （European Pharmacopeia）：欧洲药典JP（Japanese Pharmacopoeia）：日本药典CFR（Code of Federal Regulations）：美国联邦法律CFR 21 Part 11（Code of Federal Registry Part11）：联邦法规法律标题21第11部分CEP/COS（Certificate of Suitability to the monographs of European Pharmacopoeia）：欧洲药典适应性认证证书CEP认证，COS证书CTD（Common Technical Document）：国际注册用常规技术文件CTD文件是国际公认的文件编写格式，用来制作一个向药品注册机构递交的结构完善的注册申请文件EHS（Environment、Health、Safety）：环境-健康-安全管理体系HACCP（Hazard Analysis and Critical Control Point）：（保健食品）危害分析和关键控制点REACH（REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals）：欧盟规章《化学品注册、评估、许可和限制》，欧盟建立的，并于2007年6月1日起实施的化学品监管体系 ICH-Q1A：新原料药和制剂的稳定性试验ICH-Q1B：稳定性试验：新原料药和制剂的光稳定性试验ICH-Q1C：稳定性试验：新剂型的要求ICH-Q1D：新原料药和制剂的稳定性试验的括号法和矩阵法设计ICH-Q1E：稳定性数据的评价ICH-Q1F：气候带Ⅲ和Ⅳ注册申请的稳定性数据 ICH-Q2A：分析步骤验证：正文ICH-Q2B：分析步骤验证：方法学ICH-Q3A：原料药中的杂质 ICH-Q3B：新制剂中的杂质ICH-Q3C：杂质；残留溶剂的指导原则 ICH-Q4：药典ICH-Q4A：药典的同一化ICH-Q4B：各地区使用的药典正文评估和建议ICH-Q5A：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ICH-Q5B：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ICH-Q5C：生物技术产品的质量：生物制品/生物技术产品的稳定性试验ICH-Q5D：用于生物技术产品及生物制品生产的细胞基质的来源和鉴定 ICH-Q5E：生物技术产品/生物制品在工艺变更时的可比性ICH-Q6A：质量标准新原料药和制剂的检测以及可接受标准：化学物质ICH-Q6B：质量标准：生物技术产品及生物制品的检测方法和可接受标准ICH-Q7：原料药良好制造规范(ICH-Q7A的新版)ICH-Q7A：原料药的GMP规范 ICH-Q8：药物研发指南 ICH-Q9：质量风险管理ICH-Q10（PQS）：药物质量体系QA（Quality Assurance）：质量保证QC（Quality Control）：质量控制QRM（Quality Risk Management）：质量风险管理IPC （InproceicsQuality Control）：制程品质控制/中控OOS（Out of Specification）：检验结果超标 OOT（Out of Trend）：超趋势结果OOL（Out of Limit）：超出极限的结果，如温湿度等OOE （Out of Expectation）：超期望结果SAL（SterilityAssuranceLevel）：无菌保证水平灭菌后微生物的存活概率的负对数，要求≥6SAL=−lg存活率=F0D−lgN0D值：杀灭90%的微生物所需要的时间，D值越大，微生物死亡越难，D值与细菌的耐热性成正比Z值：指灭菌时间减少到原来的10%所需要升高的温度或是相同的灭菌时间内杀死99%的微生物所需要提高的温度F值：为一定温度下，给定Z值所产生的灭局效果与参比温度T0下给定Z值所产生的灭菌效果相同时所相当的时间F值用于干热灭菌F0值：为一定温度下，Z值为10℃产生的灭菌效果与120℃，Z 值为10℃时产生的灭菌效果相当的时间，t分钟内的灭菌效果相当于120℃下灭菌F0分钟的效果F0被称为标准灭菌时间，用于热压灭菌LRV：除菌过滤的对数下降值LRV=lgN0-lgN SOP（Standard Operation Procedure）：标准操作规程 DMF（Drug Master File）：药品主文件 SMF（Site Master File）：工厂主文件URS（User Requirement Specification）：用户需求标准FS （Functional Specification）：功能标准DS（Design Specification）：设计标准 DQ（Design Qualification）：设计确认IQ（Installation Qualification）：安装确认OQ（Operational Qualification）：运行确认PQ（Performance Qualification）：性能确认 RQ（Requalification）：再确认CAPA（Corrective Action & Preventive Action）：纠正预防系统，Q10的四大要素之一QbD（Quality byDesign）：质量源于设计COA（Certificate of Analysis）：分析证书/检验报告书/检验报告单 BPR（Batch Production Record）：批生产记录API（Active Pharmaceutical Ingredients）：药物活性成分，通常指的原料药 PMC（Product Material Control）：生产物料控制PC 生产控制；MC物料控制CMC（Chemistry and manufacture control）：生产和化学控制APR（Annual Products Review）：年度质量回顾 KPI（Key Performance Indicators）：关键业绩指标P&ID（Piping and Instrument Diagram）：工艺管道仪表流程图 PFD（Process Flow Diagram）：工艺流程图 UFD（Utility Flow Diagram）：公用工程流程图CIP（Cleaning in Place）：原位清洗（全自动，如针剂配制系统）WIP（Washing in Place）：在线清洁（半自动，需要手动的拆卸，如流化床）SIP（Sterilization in Place）：在线灭菌WFI （Water for Injection）：注射用水HVAC（Heating Ventilation Air Conditioning）：供热空气调节净化系统 HEPA（High Efficiency Particulate Air Filter）：高效过滤器DOP：为邻苯二甲酸二辛酯，HEPA检漏用的气溶胶PAO：聚-α-烯烃，HEPA检漏用的气溶胶 IBC（IntermediateBulkContainer）：中型散装容器BFS（Blowing Filling and Sealing）：吹-灌-封PAT （Process Analytical Technology）：过程分析技术PLC （Programmable Logic Controller）：可编程逻辑控制CPP （Critical Process Parameters）：关键工艺参数FBD（Fluid Bed Dryer）：流化床AHU（Air Handling Unit）：空气处理单元SAT （SiteAcceptance T est）：现场验收测试 FAT（Factory Acceptance Test）：工厂验收测试第二篇：GMP英文缩写1.AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备 2.API(Active Pharmaceutical Ingredient):活性药物物质即原料药 3.ANDA(Abbreviated New Drug Application):简化新药申请 4.ADR(Adverse Drug Reaction):不良反应5.BSE(Bovine Spongiform Encephalopathy):疯牛病6.BPCS(Business Planning and Control System):业务计划及控制系统7.BIA(Business impact assessment): 商业影响评估8.cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 CD(China Certification Committee for Drugs):中国药品认证委员会10.CIP(Cleaning In Place):在线清洁11.CV(Concurrent Validation):同步验证12.CDER(Center for Drug Evaluation and Research): 药品研究与评价中心13.COA(Certificate Of Analysis):分析报告单14.CFR(Code of Federal Regulation):(美国)联邦法规15.CDC(Centers for Disease Control and Prevention):疾病预防控制中心16.COS / CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书D(Certification Committee for Drugs):药品认证管理中心18.CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会19.CTD(Common Technical Document):通用技术文件20.CDC(Centers for Disease Control and Prevention): 疾病预防控制中心21.GMP(Good Manufacturing Practice):药品生产质量管理规范22.ICH(International Conference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use):人用药品注册技术要求国际协调会 23.EU(European Union):欧洲联盟24.EFPIA(European Federation of Pharmaceutical Industries Associations):欧洲制药工业协会联合会25.MHW(Ministry of Health and Welfare,Japan):日本厚生省26.JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会27.FDA(US Food and Drug Adminiistration):美国食品与药品管理局28.PRMA(Pharmaceutical Research and Manufacturers of America):美国药物研究和生产联会29.WHO(World Health Organization):世界卫生组织30.IFPMA(International Federation of Pharmaceutical Manufacturers Associations):国际制药工业协会联合会31.TQC(Tota lQuality Control),TQM(Total Quality Management): 全面质量管理32.PDCA(Plan,Do,Check,Action):计划执行检查处理33.QA(Quality Assurance):质量保证 34.QC(Quality Control):质量控制 35.QS(Quality System):质量体系36.QM(Quality Management): 质量管理37.SOP(Standard Operating Procedure): 标准操作规程38.SMP(Standard Management Procedure):标准管理程序39.SOR(Standard Operating Record): 标准操作记录 40.GEP(Good Engineering Practice):工程设计规范41.HVAC(Heating Ventilation and Air Conditioning):空调净化系统42.DQ(Design Qualification):设计确认43.IQ(Installation Qualification):安装确认44.OQ(Operational Qualification):运行确认 45.PQ(Performance Qualification):性能确认46.OOS(Out-Of-Specification):检验结果偏差，有别于偏差47.PFDS(Process Flow Diagrams):工艺流程图48.MRA(cMutual Reognition Agreements): 现场检查多边认同协议 49.DMF(Drug Master File):药物主文件50.EDMF(European Drug Master File)欧盟药物主文件51.EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 52.ORA(Office of Regulatory Affairs):药政事务办公室53.GGPs(Good Guidance Practices): 优良指南规范54.MOA(Method Of Analysis):分析方法 55.VMP(Validation Master Plan):验证主计划 56.VP(Validation Protocol):验证方案57.MSDS(Material Safety Data Sheet):物料安全技术说明书58.NDA(New Drug Application):新药申请59.OTC(Over-the-counter):非处方60.INN(International Nonproprietary Name):国际非专有名称P(the united state pharmacopeia): 美国药典62.NF(National Formulary):(美国)国家药品集63.GAP(Good Agricultural Practice):中药材种植管理规范64.GCP(Good Clinical Practice):药物临床试验质量管理规范65.GLP(Good Laboratory Practice):药物实验室管理规范66.GSP(Good Supply Practice):药品经营质量管理规范67.GUP(Good Use Practice):药品使用质量管理规范 68.SM(Starting Material):起始物料69.PMF(Plant Master File);SMF(Site Master File):工厂主文件70.EDL(List of Essential Drugs): 基本药物目录 71.PI(Package Insert):说明书72.PCT(Patent Cooperation Treaty): 专利合作条约73.PPAC(Patent Protection Association of China):中国专利保护协会 74.PIC(Person In Charge):负责人75.PDS(Pharmaceutical Development Services):整体新药研发机构 76.SPC(Summary of Product Characteristics):产品特性摘要第三篇：GMP常见英文缩写（本站推荐）GMP常见英文缩写AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备 API(Active Pharmaceutical Ingredient):活性药物物质,即原料药 ANDA(Abbreviated New Drug Application):简化新药申请ADR(Adverse Drug Reaction):不良反应BSE(BovineSpongiform Encephalopathy):疯牛病BPCS(Business Planning and Control System):业务计划及控制系统 BIA(Business impact assessment): 商业影响评估cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 CCCD(China Certification Committee for Drugs):中国药品认证委员会CIP(Cleaning In Place):在线清洁CV(Concurrent Validation):同步验证CDER(Center for Drug Evaluation and Research): 药品研究与评价中心COA(Certificate Of Analysis):分析报告单CFR(Code of Federal Regulation):(美国)联邦法规CDC(Centers for Disease Control and Prevention):疾病预防控制中心COS/ CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书 CCD(Certification Committee for Drugs):药品认证管理中心CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会 CTD(Common Technical Document):通用技术文件CDC(Centers for Disease Control and Prevention): 疾病预防控制中心 GMP(Good Manufacturing Practice):药品生产质量管理规范ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use):人用药品注册技术要求国际协调会 EU(European Union):欧洲联盟EFPIA(European Federation of PharmaceuticalIndustries Associations):欧洲制药工业协会联合会MHW(Ministry of Health and Welfare,Japan):日本厚生省JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会 FDA(US Food and Drug Adminiistration):美国食品与药品管理局PRMA(Pharmaceutical Research and Manufacturers ofAmerica):美国药物研究和生产联合会WHO(World Health Organization):世界卫生组织IFPMA(International Federation of Pharmaceutical Manufacturers Associations): 国际制药工业协会联合会TQC(Total Quality Control),TQM(Total Quality Management): 全面质量管理PDCA(Plan,Do,Check,Action):计划,执行,检查,处理QA(Quality Assurance):质量保证QC(Quality Control):质量控制QS(Quality System):质量体系 QM(Quality Management): 质量管理SOP(Standard Operating Procedure): 标准操作规程SMP(Standard Management Procedure):标准管理程序SOR(Standard Operating Record): 标准操作记录GEP(Good Engineering Practice):工程设计规范HVAC(Heating Ventilation and Air Conditioning):空调净化系统DQ(Design Qualification):设计确认IQ(Installation Qualification):安装确认OQ(Operational Qualification):运行确认PQ(Performance Qualification):性能确认OOS(Out-Of-Specification):检验不合格;超标 PFDS(Process Flow Diagrams):工艺流程图MRA(cMutual Reognition Agreements): 现场检查多边认同协议 DMF(Drug Master File): EDMF(European Drug Master File）欧盟药物主文件EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 ORA(Office of Regulatory Affairs):药政事务办公室GGPs(Good Guidance Practices): 优良指南规范MOA(Method Of Analysis):分析方法VMP(Validation Master Plan):验证主计划VP(Validation Protocol):验证方案MSDS(Material Safety Data Sheet):物料安全技术说明书NDA(New Drug Application):新药申请OTC(Over-the-counter):非处方INN(International Nonproprietary Name)国际非专有名称USP(the united state pharmacopeia): 美国药典NF(National Formulary):(美国)国家药品集GAP(Good Agricultural Practice):中药材种植管理规范GCP(Good Clinical Practice):药物临床试验质量管理规范 GLP(Good Laboratory Practice):药物实验室管理规范GSP(Good Supply Practice):药品经营质量管理规范 GUP(Good Use Practice):药品使用质量管理规范 SM(Starting Material):起始物料PMF(Plant Master File);SMF(Site Master File):工厂主文件EDL(List of Essential Drugs): 基本药物目录 PI(Package Insert):说明书PCT(Patent Cooperation Treaty): 专利合作条约PPAC(Patent Protection Association of China):中国专利保护协会 PIC(Person In Charge):负责人PDS(Pharmaceutical Development Services): 整体新药研发机构 SPC(Summary of Product Characteristics):产品特性摘要第四篇：英文缩写GM（General Manager）总经理VP（Vice President）副总裁FVP（First Vice President）第一副总裁AVP（Assistant Vice President）副总裁助理CEO（Chief Executive Officer）首席执行官COO（Chief Operations Officer）首席运营官CFO（Chief Financial Officer）首席财务官CTO（Chief Technology Officer）首席技术官HRD（Human Resource Director）人力资源总监OD（Operations Director）运营总监MD（Marketing Director）市场总监OM （Operations Manager）运作经理PM（Production Manager生产经理、Product Manager产品经理、Project Manager项目经理)注：这里面变化比较多，要结合谈话时的背景来判断究竟是指哪种身份）BM（Branch Manager）部门经理DM（District Manager）区域经理RM（Regional Manager）区域经理President 总裁Vice-President 副总裁Assistant VP 副总裁助理Executive Marketing Director 市场行政总监General Manager 总经理Branch Manager部门经理Product Manager 产品经理Project Manager 项目经理Regional Manager 区域经理Production Manager 生产经理Transportation Manager 运输经理Applications Programmer 应用软件程序员Computer Operator 电脑操作员Computer Operations Supervisor 电脑操作主管Hardware Engineer 硬件工程师Computer T echnician 电脑技术MIS Manager 管理信息系统部经理Developmental Engineer 开发工程师Operations Analyst 操作分析Director of Information Services 信息服务主管LAN Administrator 局域网管理员Systems Analyst 系统分Manager of Network Administration 网络管理经理Systems Engineer 系统工程师Product Support Manager 产品支持经理Systems Programmer 系统程序员VP Sales 销售副总裁VP Marketing 市场副总裁Senior Account Manager 高级客户经理Telemarketing Director 电话销售总监Sales Administrator 销售主管Telemarketer 电话销售员Regional Sales Manager 地区销售经理Tele-Interviewer 电话调查员Regional AccountManager 地区客户经理Salesperson 销售员Sales Representative 销售代表Merchandising Manager 采购经理Sales Manager 销售经理Marketing Consultant 市场顾问Sales Executive 销售执行者Marketing Assistant 市场助理Sales Assistant 销售助理Marketing and Sales Director 市场与销售总监Retail Buyer 零售采购员Market Research Analyst 市场调查分析员Manufacturer’s Representative 厂家代Purchasing Agent 采购代理Assistant Account Executive 客户管理助理Marketing Manager 市场经理Advertising Manager 广告经理Marketing Intern 市场实习Advertising Coordinator 广告协调员Marketing Director 市场总监Advertising Assistant 广告助理Account Manager 客户经理Account Representative 客户代表Accounting Payable Clerk 应付帐款文员Accounting Assistant 会计助理Accounting Manager 会计经理AccountsReceivable Clerk 应收帐款文员Accounting Clerk 会计文员Certified Public Accountant 注册会计师Senior Accountant 高级会计Chief Financial Officer 首席财务官Audit Manager 审计经理Collections Officer 收款负责人Auditor 审计师Junior Accountant 初级会计Loan Administrator 贷款管理员Management Accountant 管理会计Billing Clerk 票据文员Billing Supervisor 票据管理员Bookkeeper 档案管理Staff Auditor 审计员Bookkeeping Clerk 档案管理助理Budget Analyst 预算分析Tax Accountant 税务会计Credit Analyst 信用分析Credit Manager 信用管理经理Vice-President of Administration and Finance 财务行政副总裁Financial Analyst 财务分析Vice-President of Finance 财务副总裁Financial Consultant 财务顾问Financial Manager 财务经理Financial Planner 财务计划员VP HR 人力资源副总裁Assistant VP HR 人力资源副总裁助理HR Director 人力资源总监Compensation &Benefit Manager 薪酬福利经理Staffing Manager 招聘经理Training Manager 培训经理Benefits Coordinator 员工福利协调员Employer Relations Representative 员工关系代表Payroller 工资专员Training Coordinator 培训协调Training Specialist 培训专员HR Supervisor(Training)培训主管Vice-President of Administration 行政副总裁Administrative Director 行政总监Office Manager 办公室经理File Clerk 档案管理员Administration Assistant 行政助理Receptionist 接待员General Office Clerk 办公室文员Secretary 秘书Order Entry Clerk 订单输入文员Operator 接线员Typist 打字员公司部门：总公司Head Office分公司Branch Office营业部Business Office人事部 Personnel Department人力资源部 Human Resources Department总务部 General Affairs Department财务部General Accounting Department销售部 Sales Department国际部International Department广告部 Advertising Department企划部Planning Department研发部 Research and Development Department(R&D)秘书室 Secretarial Pool销售相关名词：KA：Key Accounts（原：主要客户）大卖场，大型连锁DM：DeliverMessageDirectMail 宣传单张POP：Point of the purchase(原：据点上的购买）店头广告PDCA：Plan,Do,Check,Action 计划、实施、检核、措施为管理循环的简称4PS：Product,Price,Place,Promotion 行销组合4p(产品价格通路促销)4CS：Consumer needs,Costs,Convienience,Communication行销组合4c(顾客需求顾客接受的成本便利性沟通)MINI：Mininum 小SWOT：trength,Weakness,Opportunity,Threat(优势弱势机会问题)为内外环境分析的一个工具USP：Unique Special Point 独特点FAB：Feature,Advantage,Benefit 产品特性，利益，功效推销法POD：Product Of Difference 产品的卖点SP：Sales Promotion 促销AD：Advertisement 广告NP：News Paper 报纸杂志PR：Public Relation 公共关系Store Check：Store Audit(偏于量的终端调查)终端调查，铺市率调查（可见度）FGD：Focus Group Discuss 座谈会(市调一种)Outdoor：户外GRP： Gross Rating Point（媒介用语）毛评点;总收视点3A：Avalible,Able,Adsire买得到，买得起，乐得买A&U：Attitude and Usage 消费态度和行为（市场调查）TG：端架SKU：单品CPM:每一百万个使用者会有几次抱怨(Complaint per Million)CRM:客户关系管理(Customer Relationship Management)JIT: 即时管理(Just In Time)KM：知识管理(Knowledge Management)LTC:最小总成本法(Least Total Cost)LUC:最小单位成本(Least Unit Cost)SO:订单(Sales Order)销售中的4P：产品（Product）、价格（Price）、通路（Place）、促销（Promotion）销售中的4C：消费者（Consumer）、成本（Cost）、方便（Convenience）、Inventory Control Manager 库存管理经理Regional Manager 区域经理Executive Marketing Director 市场行政总监Warehouse Manager 仓库经理Manager(Non-Profit and Charities)非盈利性慈善机构管理Cashier 出纳员Buyer 采购员Clerk/Receptionist 职员/接待员Civil Engineer 土木工程师Clerk Typist & Secretary 文书打字兼秘书Marketing Representative 销售代表Simultaneous Interpreter 同传公司英文标识总公司Head Office分公司Branch Office 营业部Business Office人事部 Personnel Department人力资源部Human Resources Department 总务部General Affairs Department财务部General Accounting Department 销售部Sales Department 促销部Sales Promotion Department 国际部 International Department 出口部Export Department进口部Import Department 公共关系Public Relations Department 广告部Advertising Department 企划部Planning Department 产品开发部Product Development Department 研发部Research and Development Department(R&D)艺术类词汇:服装设计师Fashion Designer电影摄制助理Film Production Assistant画面设计师Graphic Designer 装饰设计师Interior Designer制片协调员Production Coordinator男演员/女演员Actor/Actress艺术总监Art Director舞蹈教练Choreographer喜剧演员Comedian舞蹈家 Dancer摄影师 Photographer服务行业词汇: 办案员Case Worker城市规划者Urban Planner临床医学家Therapist社会工作者Social Worker心理学家Psychologist客户服务经理 Customer Service Manager客户服务代表 Customer Service Representative健康俱乐部经理Health Club Manager厨师Chef美容师Cosmetologist发型师Hairstylist 教育词汇:校长Principal外语教师 Foreign Language Teacher银行词汇：工商银行 ICBC: Industrial and Commercial Bank of China中国银行 BOC: Bank of China建设银行CCB: China Construction Bank农业银行ABOC: Agriculture Bank of China交通银行BOCM: Bank of Communication招商银行CMB: China Merchant Bank民生银行 CMBC: China Minsheng Banking Group,.Ltd光大银行 CEB: China Everbright Bank华夏银行 Huaxia Bank中信银行 ChinaCitic Bank广东发展银行Guangdong Development Bank深圳发展银行Shenzhen Development Bank上海浦东发展银行SPDB: Shanghai Pudong Development Bank兴业银行 CIB: China Industrial Bank Co., Ltd.MPV是指多用途汽车(multi-Purpose Vehicles)，从源头上讲，MPV是从旅行轿车逐渐演变而来的，它集旅行车宽大乘员空间、轿车的舒适性、和厢式货车的功能于一身，一般为单厢式结构，即多用途车。
美国药典标准
美国药典标准美国药典（United States Pharmacopeia, USP）是美国药典委员会（United States Pharmacopeial Convention, USPC）颁布的一部权威的药典标准，它包括了药品、药材、药品原料、药品辅料、药品包装材料等方面的标准和规定。
美国药典标准的制定是为了保障药品的质量、安全和有效性，以及保护公众的健康。
美国药典标准对药品的质量控制、生产工艺、测试方法等方面都有详细的规定，被广泛应用于美国以及其他国家和地区的药品生产和监管中。
首先，美国药典标准对药品的质量要求非常严格。
它规定了药品的成分、纯度、含量、稳定性等方面的要求，确保药品符合规定的质量标准。
这些质量要求不仅对于药品的生产企业具有约束力，也为监管部门提供了依据，保障了患者用药的安全性和有效性。
美国药典标准还对药品的包装材料、标签、说明书等方面做出了详细规定，以确保药品在使用过程中能够保持其质量和安全性。
其次，美国药典标准对药品的生产工艺也有严格的规定。
它规定了药品的生产工艺流程、设备、环境等方面的要求，确保药品的生产过程符合规范，能够保证药品的质量和安全性。
这些生产工艺的规定不仅对于药品生产企业具有指导作用，也为监管部门提供了依据，确保药品生产过程的合规性。
此外，美国药典标准还包括了对药品的测试方法的规定。
它规定了药品的质量控制测试方法、检验项目、标准物质等方面的要求，确保药品的质量能够得到准确的评价和监控。
这些测试方法的规定为药品生产企业提供了具体的操作指南，也为监管部门提供了依据，确保药品的质量符合规定的标准。
总的来说，美国药典标准是一部权威的药品质量标准，它包括了对药品质量、生产工艺、测试方法等方面的详细规定，为药品的生产和监管提供了具体的指导和依据。
遵循美国药典标准，能够保证药品的质量、安全和有效性，对于保障公众的健康具有重要意义。
同时，美国药典标准也为其他国家和地区的药品监管提供了借鉴和参考，促进了国际药品质量标准的统一和协调。
美国药典43 USP 43 硫酸软骨素钠
硫酸软骨素钠(美国药典43版)(USP 43)软骨素，氢硫酸盐，钠盐[9082-07-9]。
定义硫酸软骨素钠是线形的葡萄糖胺聚糖硫酸化的钠盐，该葡萄糖胺聚糖来源于被人类作为食物的健康及饲养的动物牛，猪或禽类的软骨。
硫酸软骨素钠主要由N-乙酰基软骨糖胺(2-乙酰氨基-2-脱氧-β-D-吡喃半乳糖)硫酸酯的钠盐和D-葡萄糖醛酸聚合物组成。
在聚合物中，这些己糖以β-1,4键和β-1,3键交替连接。
在常见的葡萄糖胺聚糖中，软骨糖胺部分被单硫酸酯化，位置主要在4位，很少在6位。
以干品计，硫酸软骨素钠的含量为不少于90.0%且不超过105.0%。
[注—硫酸软骨素钠一旦干燥极具引湿性。
应避免暴露在空气中，且应迅速称量。
]鉴别A：光谱鉴别试验<197>, 红外光谱：197K。
B：鉴别试验-常规，<191>钠，供试溶液：0.5g样品溶解于10mL水中可接受标准：符合规定C．二糖化合物：酶促消化非特定性二糖限度检查项目中的供试溶液后所得到的色谱图中显示三个主峰（酶促消化标准溶液中分别为脱水葡萄糖醛酸-[1→3]-软骨糖胺4-硫酸(△Di-4S), 脱水葡萄糖醛酸-[1→3]- 软骨糖胺-6-硫酸(△Di-6S), 和无硫脱水葡萄糖醛酸-[1→3]- 软骨糖胺(△Di-0S) ）。
峰面积响应方面，△Di-4S 值最大，△Di-6S次之，△Di-0S在三者中最小。
△Di-4S 和△Di-6S间的峰响应比值不得少于1.0。
D ．比旋度：符合特定检查项下<781S>旋光度，比旋度的要求组分硫酸软骨素钠的含量标准溶液：1.5mg/mL 、1.0 mg/mL 和0.5 mg/mL 的USP 硫酸软骨素钠RS 的水溶液。
供试溶液：取100mg 干燥的硫酸软骨素钠置于一个100mL 的容量瓶中，溶于30mL 水中，用水稀释至刻度。
稀释剂：称取约297mg 磷酸二氢钾、492mg 磷酸氢二钾和250mg 聚山梨酯80，转移至一个1L 的烧杯中。
美国药典标准
美国药典标准美国药典（United States Pharmacopeia, USP）是美国药典委员会（United States Pharmacopeial Convention, USPC）编制的一部权威的药典，用于规范和标准化药品、食品和饮料等产品的质量、纯度、效力和其他相关特性。
美国药典标准是全球范围内被广泛接受和采用的，对于保障公众健康和安全起着重要作用。
美国药典标准的内容涵盖了各种药品的制造、质量控制、标签说明、储存和运输等方面的要求。
它不仅仅是一本药品的规范手册，更是一部关于保障患者用药安全的权威指南。
美国药典标准的制定遵循着严格的科学原则和程序，确保其内容的准确性和可靠性。
在美国药典标准中，包括了药品的命名、标签、外观、性状、纯度、含量、稳定性、杂质、微生物限度、储存、包装等方面的要求。
这些要求旨在确保药品的质量稳定，能够提供患者所需的治疗效果，并减少不良反应的发生。
另外，美国药典标准还包括了药品制造过程中的质量控制要求，包括原辅料的选择和使用、生产工艺的控制、设备的验证和清洁、生产环境的控制等。
这些要求旨在确保药品的生产过程符合标准，能够生产出符合规定要求的高质量药品。
除了药品，美国药典标准还涉及到食品和饮料等产品的质量和安全要求。
这些要求包括了原料的选择和使用、生产工艺的控制、产品的质量检验、包装和储存等方面。
通过遵循这些标准，可以确保食品和饮料的质量和安全，保障消费者的健康。
总的来说，美国药典标准对于药品、食品和饮料等产品的质量和安全起着重要的作用。
它为相关行业提供了一套权威的规范和标准，帮助生产商确保产品的质量稳定，保障消费者的健康和安全。
同时，美国药典标准也为监管部门提供了一份可参考的依据，帮助他们对产品的质量和安全进行监督和管理。
在全球化的今天，越来越多的国家和地区开始采用美国药典标准，这也进一步促进了不同国家和地区之间的药品贸易和合作。
通过共同遵循美国药典标准，可以建立起一个更加统一和互认的国际药品质量标准体系，为全球公众健康和安全作出更大的贡献。
美国药典(USP)沿革及2007年版简介
美国药典（USP）沿革及2007年版简介1820年1月1日，11位医生在美国国会大厦的参议院聚会，商讨创作USP。
他们意图编出一部最佳治疗药品的汇编，给出适用的药名，并提供制剂的处方。
经过不到一年的时间，USP第一版于1820年12月15日出版。
它的前言提出，刊印药典的目的是从具有治疗效力的物质中，选择那些功能充分证实、作用明确了解的药物，并由此做出制剂，使其效力得到最大的发挥。
它也要给采用的各种药物提出一个合适而确切的名称，以防止医师与药师间交流的麻烦与不确定性。
这一要求在今天的药典中仍然如此。
随着时间的推移，USP的性质从处方汇编改变为药品标准的汇编。
它的出版周期也改变了，从1840年到1942年，每10年一版；1942到2000年，每5年一版；从2002年开始每年一版。
1888年，美国药学会出版了第一部国家处方集，名称叫非法定制剂的国家处方集，简称NF。
USP和NF是被1906年美国食品药品法和1938年的食品药品和化妆品法所认可的。
1975年USP与NF合并出版，叫USP-NF。
现在，USP根据分析和计量科学以及其他相关学科的进展，继续发展USP-NF成为提供药品标准的汇编。
USP30版与NF25版于2007年5月1日实施。
它收载了药物、生物制品、食品增补剂和赋形剂的科学标准，可用于生产各种剂型和成品。
USP30-NF25各论中所提供的所有物品（除极少数外）在美国都是法定上市的或者含在法定上市的物品中。
在USP-NP的各论中，一个物质（原料）或制品（制剂）列有该物品的定义、包装、储存、其他项以及技术要求。
技术要求包括一系列的常用试验（性状、鉴别、杂质、含量测定）和特殊试验，每项试验用一种或多种分析方法及其判定标准。
组分是指药物或赋形剂。
赋形剂是指有意加入到剂型的组方中，除了活性物质以外的任何成分，但它不一定是无活力的。
药物和赋形剂可以是合成的、半合成的、来自自然界的或用重组技术生产的。
需要效价测定的大分子和混合物通常叫做生物制品或生物技术物品。
PropyleneGlycol-USP：丙二醇-美国药典
Technical BulletinPROPYLENE GLYCOL - USP GENERIC NAMES 1,2 propanediol DESCRIPTION A relatively nontoxic liquid that is practically colorless, odorless, and tasteless. APPLICATIONSA solvent for flavors, extracts, drugs, an d food antioxidants: a heat transfer medium; an emollient and humectant and plasticize r f or tobacco products, baked goods, coconut, cellophane, cork, adhesives, and paper products; a l ubricant and mold inhibitor for food processing equipment; a humectant for pet food.SALES SPECIFICATIONS This product meets the requirements of the Propylene Glycol monograph listed in the United States Pharmacopoeia (USP), latest edition, European Pharmacopoeia (EP), and Food Chemicals Codex (FCC).Property Specifications Test Method * Acidity (as acetic acid), wt.% 0.002 max. ST-31.46, B Appearance Substantially free of suspended matter ST-30.1 Ash, wt.% 0.005 max. ST-31.12 Chlorides as CI, ppm 0.5 max. ST-4.44 Color, Pt-Co 10 max. ST-30.12 Heavy metals as Pb, ppm 5 max. ST-31.30 IR spectra Passes USP Propylene Glycol, area % by gas chromatography 99.5 min. ST-35.102 Specific gravity, 25/25°C1.0350 min. 1.0370 max. ST-30.31 Sulfate, ppm 60 max. USP Volatile organic impurities Passes USP-NF Water, wt.% 0.2 max. ST-31.53∗ Test methods are available upon request.QualiChem Technologies QualiChem Technologies warrants only that its products meet the spec ifications stated herein. Typical properties, where stated, are to be consi dered as representative of current production and should not be t re ated as speci f ications. W h ile al l the information pr esented i n thi s document i s bel ieved to be r e liable and t o r epresent the best av a ilable data on these pr o ducts, N O GUARANTEE, WARRANTY, OR REPRESENTATION IS MADE, INTENDED, OR IM PLIED AS T O T HE C ORRECTNESS OR SU FFICIENCY OF AN Y IN FORMATION, O R AS T O T HE SUITABILITY OF A NY CHEMICAL COMPOUNDS FOR A N Y PARTICULAR USE, OR THAT ANY CHEMICAL COMPOUNDS OR US E THEREOF ARE NOT SUBJECT TO A CLAIM BY A THIRD PART Y FOR INFRINGEMENT OF ANY PAT ENT OR OT H ER INT E LLECTUAL PROPER T Y RIGHT. EACH USER SHOU L D CONDUCT A SUFFICIENT INVEST I GATION T O ESTABLISH THE SUITABILITY OF ANY PRODUCT FOR ITS INTENDED USE. Products may be toxic and require special precautions in handling. For all products listed, user should obtain detailed information on toxicity, together with proper shipping, handling and storage procedures, and comply with all applicable safety and environmental standards.PROPYLENE GLYCOL – USPTYPICAL PROPERTIESChemical PropertiesStructure CHHOCH2CH3Molecular Weight 76Physical Properties Regulatory InformationArsenic, ppm 1 max DOT Classification not regulated Boiling range, Freight Classification propylene glycolASTM, °C, IBP 185 min.ASTM, °C, DP 189 max.HMIS Code 0-1-0 Flash point, PMCC, °F 212CAS Number 57-55-6 Freezing point, °C <-76TSCA Inventory listed on or exempt. Refractive index, 20°C 1.4310 min.WHMIS Classification not regulated1.4330 max.Canadian DSL listed on or exempt.<1European EINECS listed on or exempt. Vapor pressure, 20°C, mmHgViscosity, 20°C, cp 60Australian AICS listed on or exempt. Water solubility, % >10Japanese MITI listed on or exempt. Weight, 20°C, lb/gal 8.64PRODUCT SAFETY POLICYIt is the product safety policy of Q ualiChem Technologies to provide our cust omers with information on the safe handling and use of our products. The Material Safe t y Data Sheet (MSDS) should always be read and understood thoroughly before handling the product, and adequa te safety procedures should be followed. Information on the toxicity, environmental, and industri al hygiene aspects of our products m ay be found in the MSDS. Precautionary measures include: use only wit h adequate ventilation; avoid breat hing vapor, mist or gas; avoid contact with eyes, skin and clothing; keep container closed; wash thoroughly after handling.HANDLING, STORAGE, and SHIPPINGPropylene Glycol USP is a high-purity m aterial, which must be handled with special precautions to avoid contamination. Under ordinary conditions, m ild steel is a satisfactory materi a l of construction; however, for long term storage and where iron contamination and color a re objectionable, stainless steel or aluminum vessels are recommended. For additional information on handling and s torage of PG-USP, please contact the QualiChem Technologies. Product is available in b arges, lined tank cars and dedicated tank trucks, and 55-gallon non-returnable drums, 480 pounds net weigh t. Please contact us for other sizes.Certain government regulations may apply at the t ime of shipment.QualiChem Technologies。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
Poly-A 103
G11
Bis(2-ethylhexyl) sebacate polyester.
双（2乙基己基）癸二酸聚酯
G12
Phenyldiethanolamine succinate polyester.
聚乙二醇(平均分子量3,000~3,700)
Carbowax 4000
G16
Polyethylene glycol compound (av. mol. wt. about 15,000). A high molecular weight compound of polyethylene glycol with a diepoxide linker.
Carbowax 20M
G17
75% Phenyl-25% methylpolysiloxane.
75%苯基-25%甲基聚硅氧烷
OV-25
G18
Polyalkylene glycol.
聚亚烷基二醇
UCON LB 550-X
G19
25% Phenyl-25% cyanopropyl-50% methylsilicone.
[note—Available commercially as Polyethylene Glycol Compound 20M, or as Carbowax 20M, from suppliers of chromatographic reagents.]
聚乙二醇(平均分子量3,000~3,700)。聚乙二醇与一种二环氧化物粘合物的高分子合物。[注----商名聚乙二醇合物20M，或Carbowax 20M,色谱试剂商处购得]
聚丁二酸乙二醇酯
DEGS
G5
3-Cyanopropylpolysiloxane.
3-氰丙基聚氧硅烷
Silar 10C
G6
Trifluoropropylmethylpolysiloxane.
三氟丙基甲基聚硅氧烷
OV-210
G7
50% 3-Cyanopropyl-50% phenylmethylsilicone.
苯甲基二四基聚硅氧烷
（10%苯取代）
OV-3
G42
35% phenyl-65% dimethylpolysiloxane (percentages refer to molar substitution).
35%苯基-65%乙烯基硅烷
（百分比参见分子取代度）
G43
6% cyanopropylphenyl-94% dimethylpolysiloxane (percentages refer to molar substitution).
G22
Bis(2-ethylhexyl) phthalate.
双（2-乙基己基）邻苯二甲酸酯
G23
Polyethylene glycol adipate.
聚己二酸乙二醇酯
EGA
G24
Diisodecyl phthalate.
二异癸邻苯二甲酸酯
G25
Polyethylene glycol compound TPA. A high molecular weight compound of a polyethylene glycol and a diepoxide that is esterified with terephthalic acid.
苯基二乙醇胺琥珀酸聚酯
PDEAS
G13
Sorbitol.
山梨醇
Sorbitol
G14
Polyethylene glycol (av. mol. wt. of 950 to 1050).
聚乙二醇(平均分子量950-1,050)
Cyethylene glycol (av. mol. wt. of 3000 to 3700).
G45
Divinylbenzene-ethylene glycol-dimethylacrylate.
二乙烯基苯-乙二醇-二甲基丙烯酸酯
DVB-EGDMA (HayeSep T)
G46
14% Cyanopropylphenyl-86% methylpolysiloxane
14%-氰丙基苯基-86%-甲基聚硅氧烷
25%苯基-25%氰丙基-50%甲基硅氧烷
OV-225
G20
Polyethylene glycol (av. mol. wt. of 380 to 420).
聚乙二醇(平均分子量380~420）
Carbowax 400
G21
Neopentyl glycol succinate.
丁二酸新戊二醇酯
NGS
Dexsil 300GC
G34
Diethylene glycol succinate polyester stabilized with phosphoric acid.
聚乙二醇丁二酸酯，用磷酸固化
DEGS Stabilized
G35
A high molecular weight compound of a polyethylene glycol and a diepoxide that is esterified with nitroterephthalic acid.
壬基酚聚氧乙烯醚（平均乙烯氧基链长度30）；壬苯醇醚30
lgepal CO880
G32
20% Phenylmethyl-80% dimethylpolysiloxane.
20%苯甲基-80%二甲基聚硅氧烷
OV-7
G33
20% Carborane-80% methylsilicone.
20%碳硼烷-80%甲基硅
[note—A suitable grade is available commercially as “SP2100/0.1% Carbowax 1500” from Supelco, Inc. (/supelco).]
G1固定相，加少量拖尾抑制剂
[注----适用级别，商名SP2100/0.1% Carbowax 1500’’厂商Supelco Inc.,网址/supelco]
聚乙二醇及硝基对苯二甲酸酯化双环氧化物高分子合物（用硝基对苯二甲酸酯化)
OV-351
G36
1% Vinyl-5% phenylmethylpolysiloxane.
1%乙烯基-5%苯甲基聚硅氧烷
SE-54
G37
Polyimide.
聚酰亚胺
G38
Phase G1 containing a small percentage of a tailing inhibitor.
Silar 9CP
G9
Methylvinylpolysiloxane.
甲基乙烯基聚硅氧烷
UC W982
G10
Polyamide formed by reacting a C36 dicarboxylic acid with 1,3-di-4-piperidylpropane and piperidine in the respective mole ratios of 1.00:0.90:0.20.
6%氰丙基苯-94%二甲基聚硅氧烷
（百分比参见分子取代度）
624
G44
2% low molecular weight petrolatum hydrocarbon grease and 1% solution of potassium hydroxide.
2%低分子量石油烃脂和1%氢氧化钾溶液
2% low MW petroleum hydr°Carbon grease in 1% solution of KOH
25%苯基-75%甲基聚硅氧烷
DC550
G29
3,3?-Thiodipropionitrile.
3,3’-硫代丙晴
TDPN
G30
Tetraethylene glycol dimethyl ether.
四甘醇二甲基醚
Bis[2(2-Methoxyehoxy)ethy] ether
G31
Nonylphenoxypoly(ethyleneoxy)ethanol (av. ethyleneoxy chain length is 30); Nonoxynol 30.
50%-3-氰丙基-50%苯甲基硅氧烷
Silar 5CP
G8
80% Bis(3-cyanopropyl)-20% 3-cyanopropylphenylpoly- siloxane
(percentages refer to molar substitution).
80%双（3-氰基丙基）－20％3-氰丙基苯聚硅氧烷（百分比参见分子取代度）
OV-1701
G47
Polyethylene glycol (av. mol. wt. of about 8000).
聚乙二醇（平均分子量8000）
G48
Highly polar, partially cross-linked cyanopolysiloxane.
强极性，部分交联氰基聚硅氧烷
根据Based on USP32/Reagents/Solutions/Chramotograph reagents
Carbowax 20M -TPA
G26
25% 2-Cyanoethyl-75% methylpolysiloxane.
25％2-氰基乙基－75％甲基聚硅氧烷
XE-60
G27
5% Phenyl-95% methylpolysiloxane.
5%苯基-95%甲基聚硅氧烷