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...
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 ...