UI Pharmaceuticals 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.

• Quality analytical method development and validation program are critical to successfully performing GMP analytical testing. Developed and validated analytical methods are used to analyze an 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 the chemical assay, identification, related substances/impurities, or chiral purity testing on API and finished drug products 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 analytical method development and validation are performed according to FDA-ICH guidelines, client-approved protocols, and standard operating procedures.