AAIPharma understands our clients have analytical testing needs that require quality and fast turnaround times, and our regional networks of cGMP analytical laboratories is designed to provide fast and responsive service. With over 30 years of experience in analytical, biopharmaceutical and microbiological testing, AAIPharma has the experience and capability to handle your active pharmaceutical ingredient, excipient or drug product challenges.

Our offerings include

  • Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS
  • Compendial method verification and validation studies
  • Compendial microbiological testing to support drug product development, release and stability
  • Drug substance reference standard characterization studies
  • Analytical method development and validation studies for small molecules and biopharmaceuticals
  • Analytical method transfer studies for small molecules and biopharmaceuticals
  • Active pharmaceutical ingredient characterization studies, release and stability testing
  • Drug product release and stability testing
  • Stability storage and testing
  • Extractables and leachables analysis
  • Heavy metals, trace metal impurities and elemental impurity testing
  • Residual solvent as per USP <467>
  • Container and closure system integrity testing
  • Disinfectant qualification and disinfectant efficacy determinations

 

Raw Material Testing

Analytical Testing

Broad Expertise, on-time delivery and online submissions assure fast, accurate raw materials testing


Microbiological Testing

Microbiology

We have served the biotech, pharmaceutical and medical device industries for more than 30 years


Stability Testing

Stability Storage & Testing

AAIPharma conducts more than 200 stability studies a year – with full ICH and custom storage conditions