At the end of chapter Sterile Product Packaging—Integrity Evaluation <1207>, the Appendix: Definitions section defines terms as they are used in the context of this set of four general information chapters.在《无菌产品包装-完整性评估1207》一章的末尾,“附录:定义”部分定义了在这套四个常规信息章节...
cial Date: O?cial as of 1-Aug-2016Document Type: GENERAL CHAPTERDocId: 1_GUID-0AE321D5-158A-4B6F-8F2B-DB66B2342E95_1_en-USPrinted from: https://online.uspnf.com/uspnf/document/1_GUID-0AE321D5-158A-4B6F-8F2B-DB66B2342E95_1_en-US© 2020 USPC〈1207〉 PACKAGE... ...
Technologies 1207.2包装完整性泄漏测试技术 Package Seal Quality Test Methods 1207.3包装密封质量测试方法 At the end of chapter Sterile Product Packaging—Integrity Evaluation 1207, the Appendix: Definitions section defines terms as they are used in the context of this set of four general information ...
包装密封质量测试技术á1207.3ñAt the end of this chapter, theGlossarysection defines...
So far, there is the General Chapter <1207> on the evaluation of the integrity of packaging ...
The attributes and general capabilities of tests can be foundin chapter 1207.2 and are helpful inthe method selection process. 没有一种单独的包装泄漏测试或包装密封质量测试方法适用于所有产品-包装系统。在产品生命周期中,某些产品包装可能需要不止一种测试方法。根据产品生命周期阶段选择包装测试方法以及重要的...
First Supplement to USP 39–NF 34 General Information / á1207ñ Package Integrity Evaluation—Sterile Products 1 Change to read: á1207ñ PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS 1. INTRODUCTION This chapter provides guidance on the integrity assurance of nonporous packages intended for sterile...
包装密封质量测试技术á1207.3ñ At the end of this chapter, theGlossarysection defines terms asthey are used in the context of this set of four general information chapters. 在本章的最后,术语表部分定义了在这组四个一般信息章节的上下文中使用的术语。
<905>UNIFORMITYOFDOSAGEUNITS(HarmonizedChapter,OfficialApril1,2006)……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>WATERDETERMINATION……2785水测定法 <941>X-RAYDIFFRACTION……2788X光衍射 GeneralInformation通用信息 ...
成员由USP大会成员在每5年一次的会议上选举产生。专家委员会是监督USP科学和标准制定决策的机构。2020—2025年, USP共设立了专家委员会29个, 由来自41个国家和地区的996位专家组成(2021Annual Report)。其中药包材标准由通则-包装与流通(General Chapter-Pack...