API nitrosamines: method sensitivity issues
European Pharmaceutical Review
AUGUST 22, 2022
For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. Procedure under Article 5(3) of Regulation EC (No) 726/2004. 2022 [cited 30 July 2022].
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