For registering the agrochemicals, thorough information on the composition of the technical grade material must be provided to the regulatory authorities. This includes the content of active ingredient, relevant impurities, significant impurities, and other possible constituents like residual solvents, metal contaminants, etc. This information is usually provided to the regulatory authorities in the form of a 5-batch analysis report. Hence, this 5-batch analysis report becomes a core requirement for any registration of the technical material. Due to this criticality, the quality of the 5-batch analysis report becomes very important. This quality comes from a thorough screening of the material for all the impurities at significant levels, confidently assigning the structural information to each impurity and providing the most reliable quantitative data.
To achieve this, at Eurofins Advinus Limited, we usually start the 5-Batch analysis with a pre-screening of the material for its total composition which includes, active ingredient content analysis, impurity profiling, and analyzing for toxicologically significant impurities, where relevant. After this, the regular 5-batch analysis of the technical material will be conducted.
The five batch analysis studies follow the linear path listed below:
- Pre-screening of 5-batches for impurities including 3D screening
- Impurity identification and structure elucidation in consultation with the sponsor
- Isolation/synthesis of impurities required for 5-batch analysis
- GLP analysis of 5-batches using validated analytical methods for active ingredient content and impurities
- Characterization of 5 commercial batches along with reference standards by UV, IR, NMR, LC-MS/MS and/or GC-MS as applicable