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Yue Zhang

affiliation not provided to SSRN

  • affiliation not provided to SSRN

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A case study on N-nitrosamine investigation in a marketed drug: From analytical procedure validation to risk mitigation decision

Number of pages: 36 Posted: 28 Sep 2025
Yue Zhang, Sabah Houari, Thomas Van Laethem, Priyanka Kumari, Eric Ziemons, Philippe Hubert and Cédric Hubert
affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN and affiliation not provided to SSRN
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Abstract:

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N-nitrosamine impurity, LC-MS/MS, Drug safety, Pharmaceuticals, Analytical procedure validation