5-BATCH ANALYSIS

RRL has vast 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 (≥ 0.1% w/w) and borderline impurities (0.1% > x ≥ 0.06%) 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.

TECHNICAL EQUIVALENCE (5-BATCH STUDY)

  • Pre-screening and chemical profiling

  • Impurity identification and isolation

  • Reference standard synthesis

  • Screening of 5 batches using suitable techniques like GC / LC / MS / 3D spectra

  • Identification and characterization of actives and impurities by MS / 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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