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Validating New Sources With 5-Batch Studies

Challenge

An agrochemical manufacturer was considering a new Chinese source for their compound. They contacted Battelle for a 5-batch study, which included a request to complete the development and validation of four draft methods for the analysis of the 15 known impurities in the original compound.

Solution

Before conducting the formal 5-batch study, we completed method validation work and an initial screening of the compound from the new manufacturer. Our study revealed nine additional significant impurities in the newly sourced material on top of the 15 which we were expecting. We conducted additional investigations to identify each impurity, prepare certified reference standards, revalidate the methods, and successfully quantify each impurity in the five batches. We then analyzed a representative batch from an alternative Indian supplier for comparison with the Chinese material. This led to another full 5-batch study on the Indian sourced material.

Result

Our initial validation and screening work allowed us to identify the presence of unknown impurities early in the process, so there would be no surprises during the official 5-batch study. Our accurate, objective analysis enabled our client to select the most appropriate new source for their compound, and ensure that the newly sourced material met all of the technical specifications for product registration.