Specialising in bespoke analytical methods for identification, characterisation, and testing of your pharmaceutical or consumer healthcare material to aid the development and ensure continued quality control of your drug product, drug substance or raw materials.
Analytical Chemistry Services
Our team of industry experts can design and optimise novel test methods for your materials. Subsequent, phase-appropriate method validation is tailored to the ICH Q2 (R1) guidelines to provide confidence in the data produced for quality control, batch release and during the life of your stability program for conformance with regulatory guidelines and expectations.
Routine and Pharmacopoeia testing are supported by our experienced scientists who are also available to provide technical support as well as troubleshooting and problem-solving advice for any other analytical issues you may encounter.
What are your analytical needs?
UPLC coupled to a high resolution mass spectrometer for structure elucidation of unknowns
Batch Release and Stability Studies
Support includes sample storage, protocol development, analysis and reporting
Appearance and Odour
Examples include; visible and sub-visible particulates, colour, clarity and odour assessments
Including pH measurements, fluoride, pKa/Ka, viscosity, moisture content and solubility studies
Method Development, Transfer and Validation
Including drug product and substance assay by UPLC/HPLC-UV, fluorescence detection, QDA, chiral and reverse phase methods
Impurity and Contamination Centre of Excellence
Our Impurity and Contamination Centre of Excellence are experts in the identification and quantification of trace impurities in a wide range of materials used throughout the global pharmaceutical and healthcare sectors.