5 Batch Analysis
In the agrochemical industry, a preliminary '5 Batch' analysis is an essential requirement for pesticide registration
It requires the analysis of five or more production batches of the chemical. Analysis is normally performed to GLP standards where each amount of active ingredient is tested and any impurities above a set level are identified and quantified.
Studies are conducted as follows:
- 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
All work is conducted in accordance with the various global regulatory directives.
For further information, please contact us
Our 5 batch specialists are based at key laboratory locations around the world, ready to support you with your preliminary analysis.