TOC System Suitability Test According to EP 2.2.44 Using a TOC-1000e

User Benefits

- Using the EP 2.2.44 System Suitability Test Set, Confirmed (EDQM CRS) enables TOC System Suitability Test compliant with the European Pharmacopoeia (EP). - By using the optional sampler, the entire TOC System Suitability Test procedure can be automated.

Introduction

Pharmaceutical water used in drug manufacturing processes must have high safety and low impurity levels. Organic impurities are controlled based on the total organic carbon (TOC) content. Following the January 2026 revision of the European Pharmacopoeia, the EP 2.2.44 system suitability test now requires standard solutions prepared using EDQM-certified chemical reference substance (CRS) as source materials. Therefore, Shimadzu is releasing the EP 2.2.44 System Suitability Test Set, Confirmed (EDQM CRS) for satisfying that requirement. It also means that standard solutions prepared from source materials other than EDQM-certified reference substances, including USP reference standard sucrose and 1,4-benzoquinone, can no longer be used for the test. This article briefly describes an example of a System Suitability Test compliant with the European Pharmacopoeia using the TOC-1000e online TOC analyzer for pure water.

October 7, 2026 GMT