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.

Bacterial endotoxins 85: not more than 0.25 Endotoxin Unit per mL.

Sterility 71: meets the requirements.

Water conductivity 645— Perform Stage 2, Step 4 using a sufficient amount of water to perform the test. The conductivity is not more than 25 µS/cm for containers with a nominal volume of 10 mL or less at 25 ± 1; and not more than 5 µS/cm for containers with a nominal volume greater than 10 mL at 25 ± 1.

Oxidizable substances— To 100 mL add 10 mL of 2 N sulfuric acid, and heat to boiling. For Sterile Water for Irrigation 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 minutes; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 minutes. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter: the pink color does not completely disappear.

Topic/Question	Contact	Expert Committee
Monograph	Gary E. Ritchie, M.Sc. Scientific Fellow 1-301-816-8353	(PW05) Pharmaceutical Waters 05
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
85	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance
71	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 3871