ProMed’s analytical team works closely with the formulation and manufacturing groups to quickly and reliably analyze drug products using state-of-the-art techniques. Areas of expertise include development of R&D analytical methods for a wide variety of complex and/or highly potent dosage forms, phase-appropriate validation of these methods, and accelerated in vitro test methods for product lot release. ProMed has more than 2000 ft2 of analytical lab space for:
- Drug assay, impurities, and content uniformity
- Real-time and accelerated in vitro elution
- Incoming API and excipient testing and release
- Mechanical testing and surface/dimensional characterization
Key in-house instruments include:
- HPLC and UPLC
- GPC
- FTIR
- DSC
- Karl Fischer (water content)
- Rheometry
- Viscometry
- USP apparatus 1, 2, and 7
- Laser microscopy
- Tensile testing/texture analyzer
ProMed collaborates with an established local contract analytical laboratory for microbial, particulate, and other specialized testing where required.
R&D and formal stability testing (under protocol) is an integral part of the development cycle for products moving out of early-stage feasibility and into clinical development.