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Unexpected Impurities in a 5-Batch Study


An agrochemical company urgently needed to generate missing data in order to meet their product submission deadline. After another lab failed to complete the studies adequately, they contacted Battelle for help. Data from the manufacturer showed several known impurities in their technical material. They asked Battelle to perform a 5-batch analysis to determine the exact quantities of these known impurities for product registration. The work was complicated by the need to ship the samples frozen in dry ice, as well as their tight timeline for completion. 


Before conducting the official 5-batch analysis, we conducted method validation work and performed an informal screening to see if there were impurities not already disclosed by the manufacturer. Our analysis revealed important levels of unknown and unexpected impurities that had not been shown by the manufacturer’s analytical method. We conducted additional studies to confirm and identify the impurities. Then an urgent new 5-batch study was placed for a different manufacturing source of the compound.


In spite of the unexpected challenges, we were able to successfully complete the project on time and meet the registration submission deadline. The initial screening allowed our client to identify potential problems with their technical material before conducting a formal 5-batch study for registration purposes. This allowed them to complete their formal studies without surprises, and ensure that their choice of manufacturer for the technical material met all product specifications and regulatory requirements. We subsequently conducted several other projects on the same compound to test material from a number of alternative manufacturing sources and modified processes. In addition to helping them to complete their initial product submission, we also generated additional registration data for both Canada and Brazil—opening up new world markets for their product.