Sterile Water for Inhalation

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 Inhalation is prepared from Water for Injection that is sterilized and suitably packaged. It contains no added antimicrobial agents. [Note—Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms.]

2 SPECIFIC TESTS

Delete the following:

Oxidizable Substances

Sample: 100 mL

Analysis: Add 10 mL of 2 N sulfuric acid, and heat to boiling. For Sterile Water for Inhalation in containers having a fill volume of 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 0.5 USP Endotoxin Units/mL

3 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in glass or plastic containers. Glass containers are preferably of Type I or Type II glass.

Labeling: Label it to indicate that it is for inhalation therapy only and that it is not for parenteral administration.