EP Revision Response: Explanation of New Standards for TOC Testing and Reference Values by Container Volume
Are you ready to prepare for the revision of EP 12.3? A clear explanation of the new requirements for TOC testing and the standard values by container capacity.
The European Pharmacopoeia (EP) 12.3 edition, which came into effect on July 1, 2026, has significantly revised the requirements for TOC testing of pharmaceutical water. It includes mandatory use of EP CRS reference standards and the introduction of TOC criteria based on container capacity for sterilized water for injection, which will have a major impact on quality control operations in the pharmaceutical industry. This document summarizes the key points of the revisions and explains the impact on equipment performance and operations during the transition to EP reference standards.
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【What can be understood from this document】 - Main revisions of the TOC test in EP version 12.3 - Requirements for EP CRS reference standards in system suitability testing - New TOC reference values set by container volume (Method B) - Transition points for TOC testing in sterilized water for injection - Comparative evaluation results of EP reference standards and USP reference standards using Sievers TOC analyzers - Corresponding methods for validated TOC analyzers and new TOC analyzers - Necessity of firmware updates, recalibration, and equipment modifications
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【Recommended for the following customers】 - Quality control (QC) personnel at pharmaceutical companies - Personnel responsible for the operation and management of pharmaceutical water systems - Personnel involved in GMP, CSV, and validation - Companies that manufacture and export products for the European Pharmacopoeia (EP) - Those considering updates to TOC analyzers or regulatory compliance
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