In the pharmaceutical industry, one of the challenges for residual solvent analysis in active pharmaceutical ingredients or their synthetic intermediates/starting materials is the possibility of changes to the manufacturing process that may occur throughout the course of drug development. Such changes can be due to alternate synthetic routes, different drug form selections, varying crystallization/purification procedures. Any of these factors could affect the residual solvents profile. To quickly develop a specific, fast and robust analytical method, an efficient systematic approach is essential.<br/>Advanced Chemistry Development (ACD) chromatography modeling software has proven to be useful tool for liquid chromatographic method development. However, there are limited applications of this tool for residual solvents by gas chromatography. This poster will present some experiments showing how the software can assist with in GC method development. This includes a strategy for analysis of residual solvents when there are frequent changes of process procedures and prediction of retention times for new target solvents based on their physicochemical properties under existing method conditions. Evaluation of real chromatographic data with the predicted optimal separation will be presented. The benefits and limitations of such tool for aiding in validation of method robustness will be discussed.

Computer simulation software for rapid gas chromatographic method development

254th National Meeting (2017)

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