Late last week, the FDA addressed developing knowledge – and concern – about nitrosamine drug substance related impurities (NDSRIs) in a final, immediately-in-effect guidance for industry. The guidance introduces a new approach and a host of tools for risk assessment of these recently discovered impurities. However, manufacturers face tight timelines for implementing them.
Quick background on nitrosamines in pharmaceutical products
Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today.
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