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Pharmaceutical / Compendial Testing
Full-package chemical analysis of APIs, drugs, excipients, raw materials and packaging as per GMP.
We offer a full-package chemical analysis service for the quality and safety of pharmaceutical products such as API, drugs, excipients, raw materials and packaging, as per GMP standards.
Regulatory bodies require materials testing to follow the relevant pharmacopoeia monographs or in-house validated methods. We analyse pharmaceutical products and drug substances as per the latest pharmacopoeias (USP, BP, EP, IP, JP) or customer-specified procedures and specifications.
What is included
- In-house method and compendial testing (IP / BP / USP)
- Method verification and method transfer (USP <1224>, USP <1226>)
- Stability storage and analysis as per ICH guidelines
- Dissolution profiling in different media
- Forced degradation studies
- Residual solvent analysis as per USP <467>
- Elemental impurity studies (USP <232> / <233>)
- Formulation product development studies
- Cleaning or residue method development and validation