SRC will provide a 'one stop' service for our clients seeking to obtain non-GLP analysis of their Active compound and impurities associate with it. This approach saves our clients time and money, and helps to alleviate the problems and delays associated with using different contract laboratories for sequential parts of the process leading batch study reports.
The SRC approach to non-GLP batch analysis is to follow a phased programme, progressing to the next stage depending on results obtained. Typically this approach would be:
Perform general gas chromatographic or HPLC screens using flame ionisation and u.v. detection, respectively to indicate the number of significant impurities present above 0.1% w/w and to indicate borderline impurities.
The analytical chemists at SRC have over 10-15 years combined analytical experience working on agrochemical/pharmaceutical chemical entities under GLP and non-GLP compliance. This experience allows the development of robust, accurate and precise methods of analysis for use in a variety of analytical applications including impurity assays and active assays. These methods can be transferred for sponsor’s in-house purposes or used at SRC in regulatory studies.
As well as providing our clients with a source of high-quality analytical standards, SRC can also facilitate rapid re-certification of analytical reference standards which have reached their expiry date. Providing the standards have maintained their integrity, this service can help our clients to save time and money, by issuing a new certificate of analysis our clients are able to continue their studies without having to re-invest in fresh, costly standards.
The structural elucidation of chemical entities plays a key part in nearly all of SRC’s business activities. It is essential for understanding the outcomes of synthetic reactions and the identification of impurities in technical materials. Due to the prominence that structural elucidation takes in our line of work. We endeavour to have state of the art instruments and facilities at our disposal to make this process as accurate and efficient as possible.
Structure of known product arises during the process also will be characterised using well known tool such as NMR, MASS and IR