Analytical Method Development and Validation
The University of Iowa Pharmaceuticals’ (UIP) Analytical Method Development and Validation Group has extensive experience developing and validating methods for use in the testing of active pharmaceutical ingredients (API) and drug products.
- Methods are developed and validated to analyze in-process, finished product and stability samples, as well as swabs to verify the cleanliness of manufacturing equipment.
- Typically, methods for in-process, uniformity of dosage units and dissolution sample analysis are developed and validated using UV, HPLC, UPLC, or GC procedures.
- Methods used to perform chemical assay, identification, related substances/impurities or chiral purity testing on API and finished drug product are typically developed and validated using HPLC, UPLC or GC.
- Methods developed for stability sample analysis are validated to ensure they are stability indicating.
- All validations are performed according to FDA-ICH guidelines, client-approved protocols and standard operating procedures.
For more information about our analytical method development and validation capabilities please Contact Us.
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