Analytical and pharmaceutical stability storage and testing underpins the development service at Pharmaterials to progress early compounds to GMP manufacture.All our capabilities are available as standalone services and we support everything from an assay on a preclinical formulation to large stability programs on commercial product.
Analytical services include:
- Protocol writing and review
- HPLC method transfer/optimisation (cGMP)for actives (APIs, and dosage forms)
- HPLC stability indicating method development (cGMP) for actives (APIs, and dosage forms)
- ICH validation studies appropriate to the phase of development
- Forced degradation studies (APIs and dosage forms)
- Dissolution method development and validation
- Development and validation of NGI and ED methods for inhalation products
- Cleaning verification methodology development and validation
- ICH compliant walk in stability storage chambers covering all major ICH conditions with the ability to implement specific storage conditions in association with approved suppliers
- Expert interpretation, trouble shooting and IMPD support
- Testing of products entering the EU for QP release
In addition, the analytical capabilities are complemented by our physical testing capabilities which together are key for specific development programs such as inhalation and amorphous dispersion formulations.
For more information on how Pharmaterials can assist you or to request a quote please contact us for further details.