TOC Analysis for Purified Water, Water for Injection and Clean-In-Place Applications

Introduction

The changes to the US Pharmacopoeia monograph for the quality of purified water, water for injection, and clea- ning water is under review and evalua- tion by the pharmaceutical industry. The current proposed method will include the replacement of the oxi- dizable substances test by measuring total organic carbon (TOC).This test method will be used to evaluate the quality of Purified water and water for injection. The Pharmaceutical Rese- arch and Manufactures of America (PhRMA) has conducted the evaluati- on of several compounds to determine their performance as a system suitability standard. The vali- dation of the 680°C TOC combustion technique for use in pharmaceutical and other ultra- pure applications is critical to ensure adequate recovery of the system suitability standard. The primary concern to the pharma- ceutical industry of the system suitabi- lity standard is the recovery of varying concentrations of compounds. These oxidizable substances typically should have a recovery of 85-115% of theore- tical carbon concentration in the range of 0.25-10 PPM.When performing this type of application, utilizing the following parameters for the TOC- 5000 series, the full capabilities of the modern 680o catalytically aided com- bustion technique can be achieved.

October 30, 2025 GMT