TOC System Suitability Test for Sterile Water According to USP
The United States Pharmacopeia (USP) specifies that total organic carbon (TOC) content be used for management of organic impurity values permitted in bulk purified water, water for injection, in addition to sterile purified water and sterile water for injection. According to USP, TOC analyzers to be used for sterile water must satisfy the TOC system suitability test using test water having a carbon content of 8.0 mg/L, and must also be able to detect TOC at 0.1 mg/L or less.
Here, we introduce an actual example of TOC system suitability testing using the Shimadzu TOC-LCPH combustion catalytic oxidation type analyzer.
- Content Type:
- Application
- Document Number:
- LAAN-A-TC-E028
- Product Type:
- Total Organic Carbon Analysis
- Keywords:
- USP, United States Pharmacopeia, Sterile Water, TOC, TOC System suitability test, Sucrose, 1,4-Benzoquinone, Pharmaceutical, Life Science, TOC-LCPH
- Language:
- English
- File Name:
- jph515001.pdf
- File Size:
- 818kb