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- PowerPoint Presentation
General Chapter <1469> Nitrosamine Impurities was published in Pharmacopeial Forum Volume 46 Issue 5, available on-line from September 1st, 2020, for public comments The comment period ends on November 30, 2020 The JSC is responsible for addressing public comment and revising the standard as needed
- USP 1469 Nitrosamines Impurities (Classroom)
This course will provide attendees with an understanding of current regulatory guidelines and USP General Chapter <1469> Nitrosamine Impurities The course will provide an overview of sources of nitrosamines including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines
- Nitrosamine Impurities - US Pharmacopeia (USP)
Nitrosamine impurities are a probable carcinogen and can compromise quality in a drug substance or product To ensure drug product quality, manufacturers must properly assess the risk of nitrosamine formation in their products and further investigate any potential risks
- Nitrosamine impurities N - US Pharmacopeia (USP)
N-Nitrosomethylaminobutyric acid (NMBA) N-Nitrosomethylphenylamine (NMPA) General Chapter <1469> Nitrosamine Impurities Provides guidance on assessing materials for nitrosamine presence, establishing control strategies, and ensuring the performance of analytical procedures to monitor nitrosamine levels in drug products
- USP 1469 Nitrosamines Impurities (On-Demand)
USP <1469> laboratory procedure video tutorials are included with this course via an on-demand format This course includes an overview of nitrosamine sources including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines
- Safeguarding patients from nitrosamine impurities in medicines
General Chapter <1469> aligns with current scientific and regulatory approaches to ensure the appropriate control of nitrosamine impurities in drug substances and drug products It is the first step toward creation of robust public standards regarding nitrosamines in USP that help to ensure the quality and safety of the drug products
- USP 1469 Nitrosamines Impurities (On-Demand) (Japanese Subtitles)
This one-day course will provide attendees with an understanding of current regulatory guidelines and USP General Chapter <1469> Nitrosamine Impurities The course will provide an overview of sources of nitrosamines including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines
- USP Standard for Nitrosamine Impurities Becomes Official
Rockville, MD, December 1, 2021 – USP announced that its new General Chapter <1469> Nitrosamines Impurities became official today in the United States Pharmacopeia—National Formulary This new standard supports manufacturers and regulators by providing guidance on assessing materials for nitrosamine presence, establishing control strategies for these impurities and ensuring the performance
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