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Nitrosamine Impurities Deadline: Are Your Products Compliant?

The FDA recently issued guidance on nitrosamine contamination

Released By Adare Pharma Solutions

The FDA recently issued guidance on nitrosamine contamination, setting deadlines for risk assessment updates and full compliance. About 30% of approved active pharmaceutical ingredients (APIs) are prone to nitrosamine formation. This article details the guidance, explores methods to reduce impurities, and demonstrates how Adare’s unique mitigation process can help achieve compliance.

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