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.
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
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