Contract Analytical Services

Available from University of Iowa Pharmaceuticals

The University of Iowa Pharmaceuticals’ (UIP) analytical method development and validation group has extensive experience developing and validating methods for use in testing 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. All validations are performed according to FDA-ICH guidelines, client-approved protocols and standard operating procedures. Routine quality control testing is performed on in-process and finished product samples, as well as rinse or swab samples to verify cleanliness of manufacturing equipment for batches made by UIP and can also be performed on products made at other sites. Stability testing is performed according to FDA-ICH guidelines, client approved protocols and standard operating procedures. Available stability storage conditions include 80 ºC, -20 ºC, 2 to 8 ºC, 25 ºC/60 % RH, 30º C/65 % RH, 40 ºC/75 % RH, xenon-arc light cabinet, and customized conditions (such as freeze/thaw cycling). The UIP analytical method development and quality control laboratory has been routinely inspected by FDA and is fully GMP compliant.

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