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.
The rest of this content is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- Guide to Analytical Testing 2019
- Annex 1 Revisions: Let’s talk TOC and conductivity requirements for pharmaceutical water systems
- Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
- Understanding current CFR 21.11 and data integrity requirements
- Application Note: Simultaneous stage 1 conductivity and TOC lab testing of pharmaceutical water