Pharmaceutical industry practices on genotoxic impurities
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| Format: | Book |
| Language: | English |
| Published: |
Boca Raton, Florida :
CRC Press
c2015
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| Series: | Chromatographic science series
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| Subjects: | |
| Online Access: | Cover image |
Table of Contents:
- 1. Overview of regulatory guidelines on impurities and genotoxic impurities
- 2. Structural alerts for genotoxicity and carcinogenicity
- 3. Acceptable exposure calculations for impurities and selected compounds from the carcinogenic potency database
- 4. Genotoxic impurities from toxicology perspectives including cancer risk assessment, in silico, in vitro/in vigo testings, and regulatory aspects
- 5. In silico/computational assessment for the evaluation of genotoxic impurities
- 6.Preclinical assessment of genotoxic impurities an overview of current regulatroy guidance, available assays, and data interpretation
- 7. Purification of lead compounds for early toxicology profiling sucs as ames and short-term non-GLP (good laboratory practice) toxicology tests
- 8. Analysis of genotoxic impurities in pharmaceutical by gas chromatography-mass spectromatry
- 9. Control of chloroethane in raw materials and drug substances using headspace/gas chromatograghy analysis
- 10. Quantification of genotoxic impurities in active pharmaceutical ingredients
- 11. Analytical testing and control for genotoxic impurities in drug substances
- 12. Approaches to assess, analyze, and control genotoxic impurities in drug substance development
- 13. Control and analysis of genotoxic impurities in drug substance development
- 14. Salt formation of pharmaceutical compounds and associated genotoxic risks
- 15. Identification and control of genotoxic degradation products
- 16. Identifical and qualification of genotoxic impurities as leachables in drug products
- 17. Pharmaceutical industry survey on genotoxic impurities and related topics