European Pharmacopoeia EP 2.2.44 and Total Organic CarbonThis paper discusses the background behind the European Pharmacopoeia’s focus on complete oxidation of TOC in the light of the increased importance of on-line Total Organic Carbon (TOC) and conductivity measurement.
21 CFR 第 11 部分关于在线 WFI 仪器的数据完整性要求本文探讨了在 WFI(注射用水)的质量控制环节,如何配置关键质量控制的在线总有机碳(TOC)和电导率分析仪,从而帮助客户满足 FDA 对数据完整性的要求,包括 Microsoft Active Directory(微软活动目录)控件的使用以及 PDF 数据的规范导出。
Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).