Determination of Three Alkyl Camphorsulfonates as Potential Genotoxic Impurities Using GC-FID and GC-MS by Analytical QbD

Determination of Three Alkyl Camphorsulfonates as Potential Genotoxic Impurities Using GC-FID and GC-MS by Analytical QbD

Camphorsulfonic acid salts are commonly used in the manufacturing production of active pharmaceutical ingredients (APIs) and have the potential to form alkyl camphorsulfonates, which can be considered as potential genotoxic impurities (PGIs). Alkyl camphorsulfonates should be controlled using the Th...

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Bibliographic Details
Main Authors: Kyoungmin Lee, Wokchul Yoo, Jin Hyun Jeong
Format: Article
Language:English
Published: MDPI AG 2022-09-01
Series:Separations
Subjects:
GC-MS
analytical QbD
genotoxic impurity
alkyl camphorsulfonate
(Q)SAR
analytical method development
Online Access:https://www.mdpi.com/2297-8739/9/9/246

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