Our ICH stability storage services provide our customers with a holistic package from protocol to final report and with trended data analysis. Within our cGMP-certified pharmaceutical development laboratories we have qualified, mapped & monitored incubators supported by back-up emergency power, emergency call-out and contingency storage capacity over the following conditions, and in full compliance with ICH guidelines:
- -80ºC, -20ºC and refrigerated, including temperature cycling for pMDIs
- 25ºC / 60%RH
- 30ºC / 65%RH
- 40ºC / 75%RH
We routinely provide stability study services extending to a wide range of industry types including:
- Human & Veterinary Pharmaceuticals (drug substance & finished products)
- Medical Devices
- Advanced Wound Management
For the pharmaceutical industry our services are used to determine the stability of drug substance materials from our Integrated Discovery & Development teams; from late lead optimisation and candidate selection through to formulations and materials used for pre-clinical and FIH trials. We also routinely run stability studies on launched commercial products and on GMP API batches used in clinical trials and pre-clinical toxicology studies. A related service requiring controlled storage of test samples is extractable and leachables testing, please follow this link for further details.
Time point analysis:
Our unrivalled breadth of analytical techniques and applications includes solid state / materials characterisation instrumentation, chromatographic analysis and standard compendial release test methods. Analytical methods undergo stage-appropriate verification, validation and transfer from non-GMP to full ICH validation, as required. For stability-indicating chromatographic methods we have significant expertise and experience in performing targeted forced degradation studies.
Furthermore, when unknown impurities form on storage that that must be identified then our synthetic chemistry division are global leaders in the Identification, Isolation & Synthesis of impurities, including the provision of certified reference materials.