USP <643> Total Organic Carbon Recent Changes – FAQs

摘要

The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing and testing to ensure safe and effective drug products. USP Total Organic Carbon (TOC) pertains to requirements for testing pharmaceutical grade water. TOC is an important quality attribute that contributes to understanding water quality before use in critical applications. TOC is central to process control and patient safety and therefore stringent testing requirements are enforced by regulatory bodies around the world. USP <643> was revised effective May 2021 to require packaged water to have container volume-dependent TOC limits and system suitability concentrations. Whether using the Sievers M9, or another instrument for TOC analysis, now is the time to scrutinize technology and processes used to test TOC. Below are a few frequently asked questions regarding the recent USP <643> changes.