Recommendations for the Contents of a Product Specification File: Related Substances (HPLC)

Abstract

This article provides recommendations for documenting an analytical procedure for the determination of related substances by high-performance liquid chromatography in a product specification file (PSF). The article contains a description of specific aspects and a template for the typical contents and layout of the PSF section dedicated to related substances. A unified approach to the PSF content and layout will ensure error-free testing, reliable results, and streamlined regulatory assessments.

Keywords

• related substances
• quality of medicinal products
• product specification file
• hplc