AAIPharma offers a fully-integrated analytical method development, method validation and testing solution with a full complement of advanced analytical technologies. Our cGMP analytical laboratories are arranged to maximize efficiency and flexibility, from their electronic laboratory notebook (ELN) data collection to their integration with our formulation development, project management and quality systems.

AAIPharma has the flexibility to provide standalone analytical development solutions or comprehensive analytical support for pharmaceutical development programs.

Our analytical development, validation and analytical testing services include:

  • Drug substance and drug product stability indicating assays
  • Related substances, chiral purity, elemental impurity and residual solvent analysis
  • Dissolution testing with UV and HPLC backend
  • Preservative and stabilizing excipients assays
  • Phospholipid and fatty acid analysis
  • Physical & structural chemistry
  • Remedial method validation / method life-cycle evaluation studies
  • Drug substance and reference standard material characterization
  • Reference standard qualification
  • Process validation support
  • Cleaning method verification
  • Drug product comparator studies
  • Material contact studies
  • In-use and administration set compatibility studies
  • Leachables and extractables studies

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