Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP <643> for packaged water. The new limits account for varying container volumes.
USP <643> Total Organic Carbon has been revised for sterile water in containers. Acceptance criteria and system suitability for sterile packaged water are changed to be dependent on container volume. This application note outlines the new limits based on container volume and demonstrates how the Sievers M9 can fully support these changes with analytical range, accuracy, precision, and data integrity. Recommended protocol configurations outlined in this app note help users with analysis.
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