Efficient Method Development for Pharmaceutical Stability Testing

User Benefits

- LC conditions that meet a resolution criteria can be found by visualizing resolution through design space. - Utilizing predicted chromatograms allows for easy verification of separation behavior under various conditions without actual analysis. - Peaks detected in multiple chromatograms can be combined, and conditions for their separation can be explored.

Introduction

Stability tests for drug approval applications include long-term storage tests, accelerated tests, and severe tests, where changes over time in pharmaceuticals are evaluated under various exposure environments to ensure drug safety and determine shelf life. Proper separation of degradants in these environments is required for their characterization and monitoring over time. LabSolutions MD, a dedicated software for method development, supports efficient method development based on Analytical Quality by Design (AQbD). This article introduces a case study on efficiently exploring optimal separation conditions for degradants using model samples that simulate different degradants obtained from stability tests.

January 28, 2025 GMT