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5 Batch Analysis

5 Batch Analysis

JRF Global has vast experience in 5-batch analysis, with more than 300 studies performed in the last 16 years.

5-batch analysis is a prerequisite for registration of agrochemicals that is required to prove their chemical equivalence. The study requires the analysis of five representative production batches for the presence of significance impurities (≥0.1% w/w) and borderline impurities (0.1% > x ≥ 0.06%) to generate the product specification for global regulatory needs.

 

JRF Global is one of the first Asian CROs to offer 5-batch analysis. Our scientists have deep experience in conducting 5-batch analysis studies and a cumulative experience of more than 100 man-years between them.

 

We use 2D and 3D techniques of chromatography along with spectrometry, in accordance to your specific regulatory guidelines.

 

A typical 5-batch analysis protocol can be found below:

  • Scanning of 5 batches using suitable techniques like GC-MS / LC-MS /LC-MS-MS / 3 D HPLC / Ion Chromatography and ICP-OES
  • Identification and Characterizations of actives and impurities by GC-MS / LC-MS / LC-MS-MS/1H-NMR, 13C NMR
  • Method development and optimization
  • Method validation in compliance with SANCO/OPPTS guideline parameters
  • Alternate method of Analysis (Most common i.e. GC / HPLC)
  • Quantitative Analysis of all components by GC/HPLC/GC-MS/ LC-MS
  • Quantitative Analysis of Active Ingredient by alternate method GC/HPLC/GC-MS/ LC-MS

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