With extensive scientific knowledge and experience with the regulatory requirements of both the international and domestic markets, ChemPartner’s analytical development group provides strong support for drug substance and drug product development. The quality of our analytical development is backed by the experience of our highly skilled scientists and support for drug substance and drug product development activities, state- of-the-art instrumentation, close cross-functional interaction, adherence to Standard Operating Procedures (SOPs), extensive regulatory training, and quality assurance oversight. All standard tests and protocols are carried out as per ICH and USP guidelines, where applicable.
Chemical and Formulation Development Support
- Analytical methods development and validation/cross-validation
- In-process control method development
- Starting material and raw material testing
- Impurity profiling
- Impurity isolations and characterization
- Degradation product characterization
- Compatibility testing
- Accelerated, intermediate and long-term stability and forced degradation studies
- Dissolution testing
Release Testing for Drug Substances and Drug Products
- Methods development and validation
- Purity and assay (wt/wt)
- Total related substances (impurities)
- Dissolution and content uniformity
- Residual solvent quantification
- Moisture content assessment
- Counter-ion determination
- Compendia testing for elemental impurities, ROI, and LOD
- Physical property measurement
- Impurity and degradation product structural identification
- Microbial limit tests (Ch.P&USP)
- Documentation and Issuance of COA’s