Are you ready for the system suitability testing of the TOC analyzer compliant with the European Pharmacopoeia (EP 12.3) revision?
The revision of the EP that came into effect on July 1, 2026, has significantly changed the requirements for the system suitability test (SST) of TOC analyzers. After the implementation of EP 12.3, in order to clarify standardization and traceability within the EP, the standard solutions for the system suitability test of TOC analyzers must use sucrose and 1,4-benzoquinone, which are certified as EP reference substances (Chemical Reference Substances: CRS). With the EP standard solution becoming the new standard, if USP standard solutions are to be continued, it is necessary to explain the validity of adopting USP reference substances.
We have published a page on our website that explains the key points of the revision, necessary responses, considerations for continuing to use USP standard solutions, and ways to utilize EP standard solutions to reduce operational burdens. If you are considering how to respond to the EP revision, please take a look at the related links. Additionally, in the related materials, we provide detailed information on the requirements for standard solutions, reference values by container type, and comparative evaluation results using Sievers TOC analyzers, highlighting key points for quality control and regulatory compliance of pharmaceutical water.

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