Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients (3) -Analysis of Haloalcohols and Glycidol Part 1-
Haloalcohols are used as synthetic materials in pharmaceuticals, and are considered potential genotoxic impurities (PGI). In addition, glycidol has been identified as a cancer-causing agent, and has been assigned to Group 2A (probably carcinogenic to humans) in terms of carcinogenic risk by the International Agency for Research on Cancer (IARC). This Application Data Sheet introduces analysis of haloalcohols and glycidol in an active pharmaceutical ingredient (API) using the GC-MS.
- Content Type:
- Application
- Document Number:
- LAAN-J-MS-E041
- Product Type:
- Mass Spectrometry, Gas Chromatograph-Mass Spectrometry
- Keywords:
- haloalchohols glycidol impurities pharmaceutical ingredients, Pharmaceutical, Life Science, DMPK, ADME, Safety testing, GCMS-QP2010 Ultra
- Language:
- English
- File Name:
- jpo212203.pdf
- File Size:
- 128kb