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 batch 5 studies conducted to GLP/Non-GLP standards by laboratories like SRC. 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 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 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.
Manufacturing impurities are often close in chemical structure to the parent product. To obtain product approval, those manufacturing impurities present at greater than 0.1% in 5 typical production batches of the technical grade Active Ingredient (AI) or active substance require to be identified and quantified as part of registrations.
Metabolites are chemical compounds related in structure to the parent active ingredient. The active ingredient has undergone biochemical modification in vivo.
These metabolites often required to be identified, quantified, and toxicity studies undertaken on the pure metabolites, as part of GLP regulatory submissions, for approval of pesticide products.
Internal Reference Standards are chemical compounds which are required for the accurate quantification of the levels of a pesticide, related impurity or metabolite.
They are used for method validation and Quality Control purposes including GLP studies.
Degradation impurities are chemical compounds related in structure to the parent pesticide. They arise during storage (or forced degradation studies), and often required to be identified and quantified as part of the GLP regulatory submissions.
As per Customer’s interest and SRC willing to conduct synthesis.