Recommendations for the Content of a Product Specification File: Water (Karl Fischer Method)

Abstract

This article provides recommendations for documenting an analytical procedure for water determination by Karl Fischer titration in a product specification file (PSF). The article contains a description of specific aspects associated with the test and a template for the typical content and layout of the corresponding PSF section. A unified approach to the PSF content and layout will ensure error-free testing, reliable results, and streamlined regulatory assessments.

Keywords

• karl fischer method
• quality of medicinal products
• product specification file
• water