Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
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Title
Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
Authors
Keywords
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Journal
JOURNAL OF MEDICINAL CHEMISTRY
Volume -, Issue -, Pages -
Publisher
American Chemical Society (ACS)
Online
2021-03-12
DOI
10.1021/acs.jmedchem.0c02120
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- Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: A comprehensive review
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