美国药典简介总结.doc

美国药典简介 1. 标题和修订（Title and Revision）. 9 2. 药典地位和法律认可（Official status and legal recognition）? 9 2.10 药典正文(Official Text) 9 2.20 药典物品（Official Articles）. 9 2.30 法律认可（Legal Recognition）. 10 3. 与标准的符合性（Conformance to standard）. 10 3.10 标准的适用性 (Applicability of standard) 10 3.10.10 制剂、原料药、辅料的标准的适用性（Applicability of Standards to Drug Products, Drug Substances, and Excipients）. 10 3.10.20 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）? 11 3.20 一致性的标示（Indicating Conformance）. 11 4. 药典各论和通则（Monographs and general chapters）? 12 4.10 各论(Monographs) 12 4.10.10 检测程序的适用性(Applicability of Test Procedures) 12 4.10.20 接受标准(Acceptance Criteria) 12 4.20 附录（General Chapter）. 12 5. 各论组成（Monograph Components）. 13 5.10 分子式（Molecular formula）. 13 5.20 附加物质、赋形剂、组分(Added Substances, Excipients, and Ingredients) 13 5.20.10官方原料药中附加的物质、赋形剂、组分（Added Substances, Excipients, and Ingredients in Official Substances）. 13 5.20.20官方制剂中的附加物质、赋形剂、组分（Added Substances, Excipients, and Ingredients in Official Products）. 13 5.30 性状和溶解性（Description and Solubility）. 14 5.40 鉴定试验（Identification Test）. 14 5.50 含量分析（Assay）. 15 5.50.10 效价单位（生物效价）(Units of Potency (Biological)) 15 5.60 杂质和外来物质（Impurities and Foreign Substances）. 15 5.60.10 USP和NF物品的其它杂质（Other Impurities in USP and NF Articles）? 15 5.60.20 USP和NF物品中的残留溶剂（Residual Solvents in USP and NF Articles）? 16 5.70性能检测（Performance Tests）. 16 5.80 USP标准品（Residual Solvents in USP and NF Articles）. 16 6. 检验规范和分析方法（Testing practices and procedures）? 16 6.10 安全的实验室规范（Safe Laboratory Practices）. 16 6.20 自动化程序（Automated Procedures）. 16 6.30 可选择的和谐的方法与程序（Alternative and Harmonized Methods and Procedures）? 16 6.40 干燥的、无水的、灼烧的、无溶剂的（Dried, Anhydrous, Ignited, or Solvent-Free Basis）? 17 6.40.10 灼烧至恒重（Ignite To Constant Weight）. 17 6.40.20 干燥至恒重（Dried To Constant Weight）. 17 6.50 溶液的制备（Preparation of Solutions）. 18 6.50.10 过滤（Filtration）. 18 6.50.20 溶液（Solutions）. 18 6.60 完成一个实验所需多少单位（Units