Sterile Water for Injection

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 Injection 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 Injection 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

Particulate Matter in Injections 〈788〉: 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 of not larger than 1-L size. Glass containers are preferably of Type I or Type II glass.

Labeling: Label it to indicate that no antimicrobial or other substance has been added, and that it is not suitable for intravascular injection without first having been made approximately isotonic by the addition of a suitable solute.