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Successful Method Migration of the USP Quetiapine Fumarate Impurities Method to an Alliance™ iS HPLC System

Successful Method Migration of the USP Quetiapine Fumarate Impurities Method to an Alliance™ iS HPLC System
Credit: iStock

In regulated laboratories, method migration is an important aspect to move an established method from one High Performance Liquid Chromatogram (HPLC) System to the same or different HPLC system. Many regulated laboratories need to migrate methods since the laboratory contains varying HPLC instrumentation from the same or different vendors. Additionally, these laboratories may desire to upgrade their older equipment to newer technology to keep up with the increased throughput.1 Successful method migration to a new HPLC system can be challenging due to differences in the instrumentation that may affect the chromatographic results. The Alliance iS HPLC System is designed with many key features and attributes that support method migration that achieves the same if not improved results.
In this application note, we will look at how the Alliance iS HPLC System has many important elements that will help to achieve a successful method migration. The USP method for Quetiapine Fumarate Impurities will be analyzed on two legacy HPLC systems and then analyzed on the Alliance iS HPLC System to compare and evaluate the method using an unknown sample of the drug substance and the system suitability requirements found in the USP method.