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.
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.