Pharmacopoeial Analysis, and other Raw Material and Finished Product Testing
We provide GMP quality control analysis of pharmaceuticals, biopharmaceuticals and healthcare products. We routinely test APIs, excipients and drug products for compliance with appropriate standards, according to pharmacopoeia monographs and client methods.
We support you throughout the development and manufacturing process, ensuring your product’s integrity from raw material to market via excipients and API analysis, batch release, product stability studies, and method verification or validation.
Our scientists’ experience and detailed knowledge of testing to the EP (European Pharmacopoeia) testing, United States Pharmacopoeia (USP) testing, British Pharmacopoeia (BP) and Japanese Pharmacopoeia (JP) pharmacopoeial methods enables us to provide customers with dedicated support during pharmacopoeial testing. We consult and advise on the best approach, and are happy to discuss topics such as upcoming changes to the USP and how this affects your business.
Analyses using individual client methods can also be supported.
A full suite of analytical and preparation equipment means that we are able to offer chemical and physical analysis for the majority of pharmacopoeia monographs and, more specifically, those to cover all the metallic elements as well as elemental sulphur, phosphorus, selenium, bromine and iodine. We also conduct residual solvent analysis and dissolution testing.
Using subvisible particle analysis techniques, we support you in controlling the limits of contaminating particles in injectable solutions in order to protect patients, guarantee quality, and comply with relevant regulations.
We are well-versed in the requirements of:-
- European Pharmacopoeia (Ph.Eur)
- United States Pharmacopoeia (USP)
- British Pharmacopoeia (BP)
- Japanese Pharmacopoeia (JP)
- High-Performance Liquid Chromatography (HPLC)
- Fourier Transform Infra-Red (FT-IR)
- Atomic Absorption Spectroscopy (AAS)
- Inductively Couple Plasma-Optical Emission Spectroscopy (ICP-OES)
- Graphite Furnace Atomic Absorption Spectroscopy (GFAAS)
- Requirements for the majority of pharmacopoeia monographs
- Hydride Generation AAS
- Ion Chromatography
- Total Organic Carbon (TOC)