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Using an Analytical Quality by Design approach, scientists recently identified impurities in a pharmaceutical product for hypertension treatment.

AQbD Approach Improves Development of LC-MS/MS Method for Hypertension Drug Analysis

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be?

Quality by Design (QbD) | Topics