GLP 5-Batch Analysis for Technical Grade Agrochemical Products


5 batch analysis study is essential to determine the composition of the agrochemical based technical grade/pure material with respect to the active ingredient and its associated impurities. This is the first step determining the composition of technical grade material for registration to regulatory authorities.

Analytical method validation and AI analysis and impurity analysis in 5 production batches can be analysed by following mentioned guidelines

  • Brasil – ABNT NBR 14029-2016
  • Europe – Regulation (EC) 1107/2009, referencing SANCO 3030/99 rev. 5.
  • US-EPA Pesticide Assessment Guidelines OCSPP 830.1700 and 830.1800 in accordance with 40 CFR Part 158 OPPTS

The analysis of five representative random production batches for the presence of significant impurities (≥ 0.1% w/w) and toxic impurities (≤0.1% w/w) to generate the product specification for global regulatory needs.

Who should Complies: The 5-batch analysis may be performed while registering a new product developed by a manufacturer or for an existing product of another manufacturer.

Phases of Study

  • Preliminary Screening
  • Impurity Identification
  • Analytical Method Validation for Active and Impurity
  • Quantitative Analysis of Active and All Component in 5 Representative Batches

A suitable, validated analytical method is required for support of many of the required product chemistry tests. DRF can establish new analytical methods or transfer and validate existing methodology using a wide range of equipment’s.

  • UHPLC (Thermo Fisher Scientific, Dionex Ultimate 3000)
  • GC-FID (Agilent 7890B)
  • GC-MS/MS (Thermo Fisher Scientific, Trace 1300/ TSQ9K-NOVPI)
  • LC-MS/MS (AB Sciex, QTRAP 5500)
  • ICP-MS (Thermo Fisher Scientific, iCAP-RQ)
  • Dionex Ion- Chromatography (Thermo Fisher Scientific, ICS-6000)
  • FTIR (Thermo Fisher Scientific, Nicolet iS5)