GMP Small Molecules

PPD Laboratories GMP lab provides comprehensive analytical testing support for active pharmaceutical ingredients (API), intermediates, raw materials, in-process samples and finished products for all dosage forms of small molecules across all phases of drug development. PPD Laboratories has a customizable approach to all small molecule drug development programs. Support for a variety of methodologies ranges from phase appropriate analytical method development and validation to transfer of existing assays.

GMP Services and capabilities include, but are not limited to:

  • Customizable stability program design and management
  • Dissolution support (including USP Apparatus IV)
  • Physical characterization analysis
  • Release and QC testing
  • CMC consulting
  • Ability to support controlled substances, highly potent/toxic compounds, antibiotics and radioactive compounds
  • Photostability, freeze/thaw, excursion and cycling studies
  • Dosing solution analysis
  • Specialized lab teams to support dissolution, gas chromatography (GC), physical and compendial testing
  • Reference standard management