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Tag: nitrosamines

Pharmacy shopping and drug abuse
Nitrosamine

Recent Updates in the Regulation of Nitrosamine Impurities

The regulation of nitrosamine impurities has been evolving rapidly due to concerns about their potential health risks, particularly their carcinogenicity. Regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Therapeutic Goods Administration (TGA) in Australia

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Nitrosamine impurities in Active Pharmaceutical Ingredients (API) and drug products
Nitrosamine

What are Nitrosamines in the Pharmaceutical Industry ?

Dive deep into how nitrosamines, probable human carcinogens, can form during pharmaceutical manufacturing and the rigorous guidelines set by FDA and EMA to combat this risk. Discover the critical steps for risk assessment, testing, and mitigation that are ensuring drug safety worldwide.

Don’t miss out on this crucial industry insight!

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