UI Pharmaceuticals

Analytical Method Development and Validation

Analytical Method Development and Validation

For almost 45 years, UI Pharmaceuticals has provided pharmaceutical analytical method development, qualification, and validation services following cGMP requirements. Let us help you meet your analytical testing needs.

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.