The analytical facility at Selcia is accredited by the MHRA to carry out GLP / GMP analysis.
The GLP certificate allows for “Analytical” and “Physical Chemical Testing” test types. Selcia also has a GMP certificate which allows us to prepare and analyse 14C radiolabelled APIs for clinical trials.
The main function of the analytical lab is to provide QC and Certificates of Analysis for both radiolabelled and non-radiolabelled compounds. The group also has extensive experience in other areas such as HPLC method development, metabolite identification, impurity profiling, impurity isolation with identification and metabolomics by NMR analysis. The experience of the group spans all types of compounds from synthetic molecules to complex natural products from a diverse range of business areas: pharmaceutical, agrochemical, food additives, fragrance compounds, veterinary products, household chemicals, etc.
Typical GLP studies performed by Selcia include certification of materials produced both in-house and supplied by customers, identification of metabolites previously isolated, identification of metabolites from complex mixtures, impurity profiling and storage stability studies. These studies have been performed both as stand-alone studies with a Selcia study director, or as part of a customer study with a Selcia principal investigator.
We specialise in mass spectrometry and particularly GLP NMR spectroscopy.
Instrumentation in our GLP laboratory includes:
- High Field NMR, 300MHz, 400MHz and 500MHz spectrometers
- 2H, 13C, 15N, 19F and 31P probes
- Mass Spectrometry LC-MS/MS
- Analytical and Preparative HPLC