TOC System Suitability Test – Redefined According to New USP Regulations Application Note · multi N/C pharma

Introduction

The USP <643> represents the general method for TOC testing in pharmaceutical applications and provides guidance on how to qualify the analytical technique for use as well as guidance on how to interpret instrument results for use as a limit test.

The revised TOC monograph <643> was implemented with the release of USP 37. It now describes two different TOC testing approaches addressing different pure water qualities, which are “Bulk Water” (e.g., Purified Water [PF], Water for Injection [WFI], Water for Hemodialysis, and condensate of Pure Steam) and “Sterile Water” (e.g., Sterile Water for Injection [SWFI], Sterile Purified Water [SPW], Sterile Water for Irrigation, and Sterile Water for Inhalation).

This application note demonstrates that the multi NC pharma allows straightforward and reliable TOC testing for sterile water according to the newly established SST.