FDA Guidance for Industry on the AI Limits for Nitrosamine Drug Substance-Related Impurities 

FDA Guidance for Industry on the AI Limits for Nitrosamine Drug Substance-Related Impurities
In Pharmaceutical Industry today’s main concern is the identification and presence of nitrosamines in drug products and drug substances. The manufacturers of active pharmaceutical ingredients (APIs) and drug products have the findings of nitrosamine impurities which may be likely human carcinogens and require the need for risk assessment strategy for potential nitrosamines and their presence.
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