Sterile Water for Irrigation

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Sterile Water for Irrigation is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agent or other added substance.

2 SPECIFIC TESTS

Delete the following:

Oxidizable Substances

Sample: 100 mL

Analysis: Add 10 mL of 2 N sulfuric acid, and heat to a boil. For Sterile Water for Irrigation in containers having a fill volume less than 50 mL, add 0.4 mL of 0.02 M potassium permanganate, and boil for 5 min; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 min. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter.

Acceptance criteria: The pink color does not completely disappear. Alternatively, perform the test for Total Organic Carbon 〈643〉, Sterile Water. (USP 1-May-2021)

Change to read:

Total Organic Carbon 〈643〉, Procedures, Sterile Water: Meets the requirements  (USP 1-May-2021)

Water Conductivity 〈645〉, Sterile Water: Meets the requirements

Sterility Tests 〈71〉: Meets the requirements

Bacterial Endotoxins Test 〈85〉: Less than 0.25 USP Endotoxin Units/mL

3 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. The container may contain a volume of more than 1 L and may be designed to empty rapidly.

Labeling: Label it to indicate that no antimicrobial or other substance has been added. The designations “For irrigation only” and “Not for injection” appear prominently on the label.