Sterile Water for Irrigation
[Note—For microbiological guidance, see Water for Pharmaceutical Purposes
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Change to read:
![]() ![]() 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.
SPECIFIC TESTS
• 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
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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 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.
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 5807
Pharmacopeial Forum: Volume No. 38(3)
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