5-Batch Analysis

Rotam has extensive experience in 5-batch analysis. The analysis is a pre-requisite for registration of agrochemicals that is required to prove their chemical equivalence. The study requires the analysis of five representative random production batches for the presence of significant impurities and borderline impurities to generate the product specification for global regulatory needs.

 

We use sophisticated equipment including chromatography along with spectrometry in accordance to the specific regulatory guidelines.

 

A typical 5-batch analysis protocol is listed below:

  • Pre-screening and chemical profiling
  • Impurity identification and isolation
  • Reference standard synthesis
  • Screening of five batches using suitable techniques like GC-MS/LC-MS/3 D HPLC-PDA/GC-FID
  • Identification and characterization of actives and impurities by GC-MS/LC-MS/1H-NMR, 13C NMR/FT-IR
  • Method development and optimization
  • Method validation in compliance with SANCO/OPPTS guideline parameters
  • Quantitative analysis of all components by GC/HPLC/GC-MS/LC-MS

 

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