Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities 2012 covers topics such as:
- Drug Related Impurities
- Degradation Products
- Process Impurities
- Establishing specifications
- Potential Genotoxic Impurities
- Overview of Impurities in Pharmaceutical Products Requiring Control
- Drug Product Impurities and Degradation Products (ICH Q3B)
- Drug Substance Impurities (ICH Q3A)
- Residual Solvents (USP 467)
- Potential Genotoxic Impurities (FDA Guidance 2008 and EMEA Guidance 2006)
- Elemental Impurities (USP 231, 232, 233)
- General Impurities
- Elemental Impurities
- Residual Solvents
Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities 2012 brings together:
- Quality assurance or regulatory affairs personnel responsible for review or reporting of data for drug substances or drug products
- Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products
