For over 40 years, UI Pharmaceuticals has provided pharmaceutical analytical method development and validation services. Let us help you meet your needs.


Analytical method Development and Validation

Lyophilization Cycle Development


Clinical Supply Manufacturing


Small Scale Commercial Manufacturing


Analytical Method Development and Validation


Routine Quality Control Analysis


Stability Assessment


Formulation Development


Comparator Products


Powder in a Bottle


Preformulation Studies


Active Pharmaceutical Ingredient (API) and Excipient Release Testing


QP Release Services


Analytical Method Development & 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.

  • A quality analytical method development and validation program is critical to successfully performing GMP analytical testing. Developed and validated analytical methods are used 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 analytical method development and validation is performed according to FDA-ICH guidelines, client-approved protocols, and standard operating procedures.

Column Being Installed on HPLCFor more information about our analytical method development and validation, Contact Us.


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