Challenges and risks associated with impurity profiles in technical grade crop protection products produced semi-synthetically from natural products
Peter Maienfisch
Abstract
The safety of crop protection products and their safe use is of paramount importance and requires that crop protection products are consistently marketed and used worldwide in the required registered quality. To meet these high-quality requirements, the highest demands must be placed on the production and purification of technical-grade crop protection products. In this context, impurity profiles are of utmost importance, as unknown impurities at higher than registered concentrations may pose new unknown toxicological risks to users, consumers, and the environment. Particularly high demands are placed on the production and purification of technical grade semisynthetic derivatives of fermentatively derived natural products to meet the required regulatory specifications, to ensure that relevant impurities do not exceed maximum allowable concentrations, to ensure the safe use of such products, and to eliminate any unknown product safety risks. The challenges associated with the manufacture and purification of Afidopyropen and the product safety risks associated with various qualities of technical grade Emamectin benzoate are discussed in detail.