Analytical chemistry is a major part of every pharmaceutical development project. Within Recipharm we have several state-of-the-art labs and scientists with experience from a variety of APIs and projects. Within Recipharm’s Analytical Development Centre of Excellence we benefit from more than 1000 years of experience, available to the benefit of our clients.
We are engaged from early preformulation with compatibility studies and physical characterisation, we do the bioanalyses from the first clinical trials and we are there through the development of the formulation, developing robust analytical methods for every purpose. We design the stability studies and help submit the results. We are also there throughout the life of the product to perform follow-up stability analyses for major big pharma product ranges. We transfer the validated methods to the final manufacturing site.
In order to drive every project to market in the fastest and most cost-effective way, our labs have different specialities. For pre-formulation, GMP might not be needed whereas when it comes to validation activities the labs are fully compliant. For major stability packages, a service with paperless operations is beneficial to ensure data integrity and ease of transferring results directly into customer systems (e.g. LIMS).
- HPLC/UPLC (UV/VIS, DAD, RI, FLD)
- HPLC (MS, MS/MS, MS/MC)
- UPLC (PDA, FLR, Q-TOF)
- GC (MS, head space)
- TGA, DSC and atomic absorption spectrometers
- Ion chromatography
- ICP OES
- TOC meter
- Laser diffraction particle size distribution
- Automated dissolutions (incl type IV)
- Karl Fischer
- Franz diffusion cell apparatus