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- PowerPoint Presentation
USP NITROSAMINE IMPURITIES JOINT SUBCOMMITTEE (JSC) - JSC CHARGE and Deliverables The JSC charge is the development of a roadmap and guide for USP for developing public standards and assist USP efforts in other activities related to Nitrosamines topics
- 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 - US Pharmacopeia (USP)
Background Since 2018, high levels of nitrosamine impurities (probable human carcinogens after long-term, chronic exposure) have been found in commonly prescribed blood pressure medicines, antacids, diabetes drugs, anti-tuberculosis, and smoking cessation medicines These impurities pose a risk to patients and have resulted in drug recalls that left millions without the treatments they depend on
- USP Standard for Nitrosamine Impurities Becomes Official
Rockville, MD, December 1, 2021 – USP announced that its new General Chapter 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 of
- USP_NitrosaminesInfographic_V5 copy
Nitrosamine Impurities: Keeping Medicines Safe What are nitrosamines? Nitrosamines are chemicals that are naturally found in water and foods Since 2018, elevated levels of these impurities have been discovered in some commonly prescribed medications
- USP Reference Standards
USP Reference Standards are used to demonstrate identity, strength, purity, and quality for medicines, dietary supplements, and food ingredients
- Safeguarding patients from nitrosamine impurities in medicines
Nitrosamine impurities can originate from different sources such as active pharmaceutical ingredient synthesis, drug product manufacturing, or drug product degradation during storage Changes in manufacturing and storage—however small they may seem—could have great impact on drug quality and, most importantly, on patients
- USP Science - US Pharmacopeia (USP)
May 2023 When unsafe levels of nitrosamine impurities were first detected in medicines in 2018, the focus was on small di-alkyl nitrosamines (e g , NDMA) in sartans Regulators around the world issued recommendations for risk assessment and mitigation, while they faced the unenviable challenge of balancing the public health risk of exposure to nitrosamines against the impact of disruptions to
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