
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.
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TECHNICAL EQUIVALENCE (5-BATCH STUDY)
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Pre-screening and chemical profiling
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Impurity identification and isolation
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Reference standard synthesis
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Screening of 5 batches using suitable techniques like GC / LC / MS / 3D spectra
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Identification and characterization of actives and impurities by MS / NMR / FT-IR
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Method development and optimization
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Method validation in compliance with SANCO / OPPTS guideline parameters
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Quantitative Analysis of all components by GC / HPLC / GC-MS / LC-MS


