Application Note: Simultaneous stage 1 conductivity and TOC lab testing of pharmaceutical water
The United States Pharmacopeia and National Formulary (USP-NF) has been the official compendia under the United States Food and Drug Administration (FDA) since the Pure Food and Drug Act of 1906…
Within the USP-NF regulations, there are four tests mandated of water for pharmaceutical purposes including Ultra-Pure Water (UPW), Water for Injection (WFI), Water for Hemodialysis, and Pure Steam.
These four tests include conductivity, Total Organic Carbon (TOC), endotoxin, and bioburden. These tests are mandated to ensure product integrity, efficacy, and patient safety. Failure to comply with these regulations can have consequences ranging from product recall to endangering patient safety. As such, there is a high emphasis and scrutiny on the deployment of the analytic methods prescribed for each of these regulations.
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