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

Post time 2024-5-16 11:35:55

journal：Organic Process Research & Development

Authors：Razvan C. Cioc; Ciarán Joyce; Monika Mayr; Robert N. Bream

Published date：2023-10-20

DOI：10.1021/acs.oprd.3c00153

PDF link：https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00153

Article link：http://dx.doi.org/10.1021/acs.oprd.3c00153

Article Source：American Chemical Society (ACS)。

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Post time 2024-5-16 11:35:56

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

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