Michael W. Dong | Authors

Highlights of the new high-performance liquid chromatography, mass spectrometry, and chromatography data systems introduced over the past year.

In the pharmaceutical industry, method validation is essential. But what are the best practices? We review regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools.

This article is first in a series of two white papers on stability studies and testing of pharmaceuticals, which focuses on the development of stability-indicating high performance liquid chromatography (HPLC) methods for drug substances and products. It provides an overview of the fundamentals, including the traditional approaches, as well as modern trends and software tools for expediting the process. The regulatory guidance on the necessary contents of a well-written method, strategies for efficient method execution, and life cycle management of analytical procedures, are described in Part 2 of the series.

Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.