EMA updates on Nitrosamine Impurities: new substances of interest and related deadlines

As reported in the latest revision “EMA / 409815/2020 Rev.2” of 26th of February 2021, the risk assessment and related testing on APIs, drugs and excipients for nitrosamine impurities detection is also extended to biological molecules.

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Latest update: 19/03/2021 10:23:57

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