Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Cioc, RC; Joyce, C; Mayr, M; Bream, RN

Bream, RN (通讯作者)，European Med Agcy, Domen Scarlattilaan 6, NL-1083 HS Amsterdam, Netherlands.

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2023; 27 (10): 1736

Abstract

The detection of N-nitrosamine impuritiesin medicinesand the recent emergence of nitrosamine drug substance related impurities(NDSRIs) has posed a gre......

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