Identification and validation of potential genotoxic impurities, 1,3‐dichloro‐2‐propanol, and 2,3‐dichloro‐1‐propanol, at subtle levels in a bile acid sequestrant, colesevelam hydrochloride, using hyphenated GC–MS technique

Potential genotoxic impurities (PGI) and N‐nitrosamine impurities in active pharmaceutical ingredients (APIs) and their determination at low levels are substantial challenges for cholesterol‐lowering agents in recent years. Herein we developed a robust, reliable, rapid, accurate and validated techni...

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Veröffentlicht in:	Biomedical chromatography 2023-01, Vol.37 (1), p.e5528-n/a
Hauptverfasser:	Kumar, S. R. Jythesh, Reddy, Junuthula Venkata Ramana, Rao, Vandavasi Koteswara
Format:	Artikel
Sprache:	eng
Schlagworte:	1-Propanol analytical method development & method validation Bile Acids and Salts Colesevelam Hydrochloride DNA Damage Gas Chromatography-Mass Spectrometry - methods GC–MS Hypolipidemic Agents potential genotoxic impurities (PGI) Propanols selected ion monitoring
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