Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients
Chemicals such as methanesulfonic acid (mesylate), benzenesulfonic acid (besilate), and p-toluenesulfonic acid (tosylate) are used in the process of synthesizing active pharmaceutical ingredients. These compounds are likely to generate sulfonic acid ester as a reaction byproduct. These compounds are known as potential genotoxic impurities (PGI) and are a significant cause for concern among pharmaceutical manufacturers. This article introduces the analysis of sulfonic acid esters utilizing the GCMS-QP2010 Ultra.
- Content Type:
- Application
- Document Number:
- LAAN-J-MS-E018B
- Product Type:
- Mass Spectrometry, Gas Chromatograph-Mass Spectrometry
- Keywords:
- sulfonic acid esters, PGI, Potential genotoxic impurities, Pharmaceutical, Life Science, GCMS-QP2010 Ultra
- Language:
- English
- File Name:
- jpo212073.pdf
- File Size:
- 303kb