Michael W. Dong | Authors

This installment is the third in a series of three articles on stability testing of small-molecule pharmaceuticals. This article provides a comprehensive and updated overview of the validation of stability-indicating methods for drug substances and drug products, and addresses regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools. Examples of generic protocols, reporting templates, and data summaries are included as supplemental reference resources.

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.

Our annual review of new high performance liquid chromatography and mass spectrometry instruments, chromatography data systems (CDS), and related products, including a summary of their significant features and user benefits.