Screening
To obtain registrations, manufacturing impurities present at greater than 0.1% in the technical grade active substance are required to be identified and quantified as part of 5 batch studies conducted to GLP standards by accredited laboratories.
Our expert knowledge of the chemistry which is used in the manufacturing process is combined with our analytical expertise using in-house instruments such as GC-MS or LC-MS-MS to deduce the correct structure of significant impurities present in our client’s pesticide samples.
We then produce expert reports which fully describe the impurity identification work, and which estimate the cost of preparation of analytical reference standards of significant impurities which are required for GLP 5 batch analysis.
We offer a screening service using our in-house GC-MS and LC-MS-MS instrumentation to enable clients to choose the best source, from a number of rival producers of technical grade pesticides, to take forward into GLP 5 batch analysis.
Our approach is based on determination of the purity of the active material, the number and identity of significant impurities, and the estimate of cost of purchase or custom synthesis of analytical standards of significant impurities.
This information, in conjunction with other commercial information, then enables our client to estimate the likely costs for GLP analysis of the purity / impurity profile of 5 typical production batches from competing producers, resulting in selection of the best source of the technical grade active ingredient.
Once the best source has been chosen, EPP Ltd can start to undertake GLP 5 batch analysis on material provided by this supplier.