5 Batch Analysis

IIRT has boasts extensive expertise in 5-batch analysis, We are specializes in providing and conducting 5-batch analyses as mandated for agrochemical registration, verifying chemical equivalence. having conducted over 400+ studies within the past years alone.AS we are the best five batch analysis company in India the five batch analysis involves representative production samples from five batches, scrutinizing for significant impurities (≥0.1% w/w) to establish product specifications complying with Indian and global regulatory standards. As We know that The analysis of five representative production batches is a crucial step in the registration of agrochemicals industries. 

Outlined below is a typical 5-batch analysis protocol:

  • Five Batch analyses Studies employing advanced techniques like GC-MS / LC-MS / LC-MS-MS / 3 D HPLC / Ion Chromatography and ICP-OES.
  • Identification and Characterization of actives and impurities through GC-MS / LC-MS / LC-MS-MS / 1H-NMR, 13C NMR.
  • Method Development and Optimization.
  • Validation of methods adhering to BIS/ISO/CIPAC/OPPTS guideline parameters.
  • Alternate Analysis Methods.
  • Quantitative Analysis of all components using GC/HPLC/GC-MS/LC-MS.
  • Quantitative Analysis of Active Ingredients using alternate methods via GC/HPLC/GC-MS/LC-MS.

Anticipated impurities within technical pesticide products, characterized by a known manufacturing process and raw material origin, follow a defined scope. These impurities generally include raw materials not consumed, unutilized intermediates, and resultant by-products.

Understanding the nature of the manufacturing process eliminates blind analysis, narrowing down potential impurities to specific categories such as raw materials, intermediates, and by-products.

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