第3类是性能测定标准, 包括保护性功能性生物反应性性能等的测试方法, 如<87><88><382><671>等。第4类属于通用信息, 对涉及不同种类药包材的使用评价完整性评价功能性评价相容性研究评价规范等内容加以说明, 包括<1031><1381><1382><1178><1207><166...
Of f i cial Date: Of f i cial as of 1-Aug-2015Document Type:GENERAL CHAPTERDocId:1_GUID-D1C4D166-C281-45AA-893A-F324F3C79190_2_en-USPrinted from:https://online.uspnf.com/uspnf/document/1_GUID-D1C4D166-C281-45AA-893A-F324F3C79190_2_en-US© 2020 USPC〈 〈 1664 ....
Accompanying <1664> is General Chapter <1664.1>, which addresses specific considerations for leachables in metered dose inhalers, nasal sprays, dry powder inhalers and inhalation solutions, suspension, and sprays. General Chapter <1664.1> is intended to incorporate into USP’s chapters specific best ...
(1664)中,有包装系统检验方面的更多相关信息。 容器-封闭物完整性 包装系统的密闭或者密封应保证能够防止内容物被污染或者内容物损失。相关的容器完整性验证, 必须证明无微生物渗透性污染,或者针对产品防护所必要的化学或物理参数没有出现增减(参见包装完
extractables and Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉 for leachables) for insights on how to design and execute relevant studies. Considering the packaging system as the test article, the intent of 〈661.2〉 is to de ne and delineate...
Combined Index to USP 38 and NF 33, including First Supplement The following Index is for convenience and informational use only and shall not be used for interpretive purposes. In addition to official articles, this Index may also include items recently omitted from the USP–NF in the ...
传送:USP 44 - NF 39 通则及指导原则目录译文(1) - 博普智库 (bopuyun.com) 1041 生物制品 BIOLOGICS 1043 细胞、基因和组织工程产品的辅料 ANCILLARYMATERIALS FOR CELL, GENE, AND TISSUE-ENGINEERED PRODUCTS 1044 细胞的低温保存 CRYOPRESERVATION OFCELLS 1046 基于细胞的先进疗法和基于组织的产品 CELL-...
1、 USP29-通用章节指导目录(附录) 第15页 共7页Guide to General Chapters 通用章节指导(标注底色部分为USP40-NF35新增章节)General Requirements for Test and Assays检查与含量分析的一般要求1INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)PRODUCT QUALITY TESTS 注射和植入药物产品(注射用) 产品质量测试1...
(for additional information, see Assessment of Drug ProductLeachables Associated with Pharmaceutical Packaging/Delivery Systems á1664ñ).Additionally, information provided by the vendor(s) of plastic packaging systems and their associated materials or compo-nents of construction can facilitate suitability ...
递送系统相关可萃取物的评估<1664>ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS与药品包装/递送系统相关可浸出物的评估<1664.1>ORALLY INHALED AND NASAL DRUG PRODUCTS 口头吸入和鼻药物产品 SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS 半固态药物产品-性能测试<1730>...