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Regulatory Science Services >> Our Services >> 5-Batch Analysis

5-Batch Analysis

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In the agrochemical industry, a preliminary '5 Batch' analysis is an essential requirement for product 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. All work is conducted in accordance with the various global regulatory directives. Our 5-batch specialists are based at key laboratory locations around the world, ready to support you with your preliminary analysis.

Our 5-Batch analysis services include:

  • 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

 Contact erssinfo@eurofins.com for more information!