Development and validation of determination of genotoxic impurity Bromoethane in Vigabatrin drug substance using head space gas chromatographic method [HS-GC]

• Main Authors: Krishan Prasad Narapereddy (Author), Devi Sravanthi Alladi (Author)
• 格式: 图书
• 出版: Pensoft Publishers, 2023-03-01T00:00:00Z.
• 主题: article
• 在线阅读: Connect to this object online.

A specific HS-GC method has been developed, optimized, and validated for the determination of genotoxic impurity Bromoethane in Vigabatrin (VGB) drug substance. Chromatographic separation of genotoxic Bromoethane impurity was achieved on DB-1 column (30 m × 0.53 mm, 5.0 μm), consists of 100% dimethy...