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.

USP Reference standards 11—
USP Endotoxin RS.

Bacterial endotoxins 85— It contains less than 0.5 USP 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 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 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.

Expert Committee : (PW05) Pharmaceutical Waters 05

USP31–NF26 Page 3523

Phone Number : 1-301-816-8353