chemistry function serves to provide the following core analytical and
– Five-Batch Analysis
Due to the bespoke nature of such studies, we work closely with Sponsors to design the studies to suit the test item and their requirements. Often this can involve a stepwise process to elucidate the profile of the batches of technical grade material and instigate the required impurity identification and reference standard synthesis procedures.
The main batch analysis study would then be conducted to fulfil the regulatory requirements to quantify all components at levels above 0.1%, as well as determine relevant impurities to fulfil the specification of the test item.
– Certificates of Analysis
Analysis of formulations, technical materials and reference standards in order to provide product certification.
Studies can be designed to include additional analyses, such as spectral determinations, water content determinations and so forth to fully characterise a test item.
– Method Validation
Studies can be conducted to support a range of requirements:
– active substance and impurity determinations for five-batch analysis studies.
– assay of the active substance in formulated products.
– determination of relevant impurities in technical grade and/or formulated products
– Dose Verification
of analysis can be developed, validated and used to verify the amount of test
item administered during both terrestrial and aquatic in-house ecotoxicology
If suitable methods of analysis cannot be supplied for the above, then our chemists have a wide range of experience to develop analytical methods for your compound.
In addition to the core analytical services described above, we would be happy to discuss any other analytical needs you may have.