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Simplifying the Process: Automated USP 643 / EP 2.2.44 Purified Water and Water For Injection Testing Using A Next Generation Total Organic Carbon (TOC) Analyzer
Industry: Pharmaceutical
Instrument: Fusion Total Organic Carbon (TOC) Analyzer
The United States Pharmacopoeia (USP) <643> and European Pharmacopoeia (EP) 2.2.44 monographs provide guidelines and requirements for Total Organic Carbon (TOC) analysis of water for injection and purified water. These methods present a system suitability test that compares the recovery of a standard solution (rs) of sucrose, a relatively easy compound to oxidize, and the system suitability solution (rss) of 1,4-benzoquinone, the challenge compound. The response of reagent water (rw) is subtracted from each of these solutions’ responses to yield a corrected response. The maximum carbon concentration of the reagent water per these monographs is 100 ppb C. However, when reagent water concentrations are below 50 ppb C, greater accuracy may be obtained through lower instrument / reagent blank values. From the results, a response efficiency (E) is calculated by dividing the corrected system suitability solution response by the corrected standard solution response and multiplying by 100. According to both pharmacopoeias, the response efficiency must achieve between 85% - 115% for the instrument to be suitable for total organic carbon (TOC) analysis on pharmaceutical pure water (PW) and water for injection (WFI) samples.
Applications
