1. Development of Quality Specifications and Analytical Methods for New Products
- Compendial monographs: For products with established monographs in pharmacopeias.
- Non-compendial monographs: Reference to ICH guidelines, general monographs, and other authoritative sources, especially for parameters such as dissolution, impurities, and nitrosamines.
2. Analytical Method Validation
- Assay
- Dissolution (tablets, coated tablets, enteric-coated tablets, sustained-release tablets)
- Impurities
- Content uniformity
- Residual solvents in excipients
- Residue from cleaning validation of facility, equipment
3. Analytical Method Transfer
Steps involved in transferring analytical data and methods between laboratories in cases:
- Technology transfer from another company
- Transfer from R&D analytical group to Quality Control
4. Dissolution Profile Testing
- Solubility studies of active pharmaceutical ingredients (APIs)
- Selection of suitable solubilizing agents for poorly soluble APIs
- Investigation and selection of appropriate dissolution test conditions
- Comparison and conclusion of results
5. Troubleshooting Common Analytical Issues
- Assay of intermediates and finished products: High levels of active ingredient compared to the theoretical amount.
- Liquid chromatography: Instable retention time; asymmetry factor and theoretical plate number not meeting specifications; unexpected results despite using pharmacopoeial conditions; inappropriate solvents or mobile phases.
- Common equipment-related issues.
