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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

From Teledyne Instruments

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. 1,2 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 (see Equations 1 & 2). 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.

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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...

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