New USP Sterile Water Testing Requirements

Overview:

On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to these monographs describe new test requirements for Total Organic Carbon Chapter and will directly affect the validation and intended use of new or existing TOC analyzers used for laboratory analysis. The deadline to comply with these new requirements is August 31, 2013.

On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to these monographs describe new test requirements for Total Organic Carbon Chapter <643> and will directly affect the validation and intended use of new or existing TOC analyzers used for laboratory analysis. The deadline to comply with these new requirements is August 31, 2013.

 

Author: GE Analytical Instruments

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