Compliance and Regulatory Considerations for the Implementation of the Multi-Attribute-method by Mass Spectrometry in a Quality Control Laboratory.

Annick Gervais,Eef H. C. Dirksen,Thomas Pohl,Karoline Bechtold-Peters,Will Burkitt,Valerio 'Alessio,Simone Greven,Andrew Lennard,Xue Li,Christopher Lossner,Ben Niu,Dietmar Reusch, Tomas O'Riordan,Justin W. Shearer,David Spencer,Wei Xu,Linda Yi

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS（2023）

Cited 4|Views27

Key words

Liquid chromatography mass spectrometry,Multi-attribute method,Quality control,Analytical target profile,Critical quality attributes,New peak detection,Compliance,Regulatory submission

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