Case Study

Unexpected Impurities in a 5-Batch Study

Unexpected Impurities in a 5-Batch Study

Pages 2 Pages

Unexpected Impurities in a 5-Batch Study Challenge 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. Solution 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 t

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