Sterile Water for Irrigation [NoteFor microbiological guidance, see Water for Pharmaceutical Purposes 1231. ] 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 boiling. 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. • Water Conductivity, Sterile Water 645: Meets the requirements • Sterility Tests 71: Meets the requirements • Bacterial Endotoxins Test 85: Less than 0.25 USP Endotoxin Unit/mL 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. • USP Reference Standards 11 USP Endotoxin RS Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 5041 Pharmacopeial Forum: Volume No. 35(5) Page 1179 |