2020年7月,USP启动了一系列针对遗传毒性杂质和药品质量的培训活动(Genotoxic Impurities and Drug Quality--Lessons from the Nitrosamine Contamination Crisis),以提高业界对遗传毒性杂质的认知;2020年9月,USP发布通则“<1469>亚硝胺杂质”征求意见稿,主...
The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary. On Dec. 2, 2021, the United States Pharmacopeia (USP)’s new General Chapter <1469> “Nitrosamines Impurities” became official in the ...
cial Date: 1-Dec-2021Document Type: GENERAL CHAPTERDocId: 1_GUID-C97F817C-A383-4693-8E0C-2F0A0A371977_2_en-US© 2021 USPCAdd the following:▲〈1469〉 NITROSAMINE IMPURITIES1. INTRODUCTION2. NITROSAMINE IMPURITIES3. SOURCES OF NITROSAMINES3.1 Nitrosamine Formation Reaction4. NITROSAMINE RISK ...
usp凡例 中英对照.doc,General Notices and Requirements凡例Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia应用于美国药典的标准、测试、定量分析、其他质量标准The General Notices and Requirements (hereinafter r