Sterile Water for Irrigation
[Note—For 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.
Topic/Question Contact Expert Committee
Monograph Antonio Hernandez-Cardoso, M.Sc.
Senior Scientific Liaison
1-301-816-8308
(GCCA2010) General Chapters - Chemical Analysis
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 5041
Pharmacopeial Forum: Volume No. 35(5) Page 1179