Case Study

Validating New Sources with 5-Batch Studies

Connect with an expert opens in a new page


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.

The 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.
Let us Battelle experts find you your solutions. Contact us today to learn more.
Connect with an expert opens in a new page

The Outcome

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.
Our Crop Protection Solutions are designed to address agriculture's most complex challenges.
Explore Crop Protection Solutions opens in a new page

Case Studies

Technology Commercialization and Licensing

With over 90 years of research and development experience, Battelle supports all areas of industry with intellectual property licensing focused on bringing our cross-disciplinary expertise to meet our clients' most difficult challenges.

Explore our ip

Photo: Abstract photo of a lightbulb