Sterile Water for Inhalation
[Note—For microbiological guidance, see Water for Pharmaceutical Purposes
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Change to read:
![]() ![]() 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. ]
SPECIFIC TESTS
• 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
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• Total Organic Carbon, Sterile Water
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• Water Conductivity, Sterile Water
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• Sterility Tests
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• Bacterial Endotoxins Test
![]() ![]() 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.
Change to read:
• USP Reference Standards ![]() ![]() ![]() ![]()
USP Endotoxin RS
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
USP38–NF33 Page 5806
Pharmacopeial Forum: Volume No. 38(3)
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