สารบัญ

Category Pharmaceutic aid (solvent).

      Sterile Water for Inhalation is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agents.

(Note Sterile Water for Inhalation is intended for use in inhalators and in the preparation of inhalation solutions. Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms.)

Description Clear, colourless liquid; odourless.

Packaging and storage Sterile Water for Inhalation shall be kept in glass containers, preferably of Type I or Type II glass, or plastic containers.

Labelling The label on the container states (1) that it is for inhalation therapy only; (2) that it is not for parenteral administration.

Oxidizable substances To 100 ml add 10 ml of 1 M sulfuric acid, and heat to boiling. For Sterile Water for Inhalation in containers having a fill volume of less than 50 ml, add 0.40 ml of 0.020 M potassium permanganate, and boil for 5 minutes; where the fill volume is 50 ml or more, add 0.20 ml of 0.020 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 colour does not completely disappear.

Water conductivity Complies with the “Water Conductivity” (For Sterile Water, Appendix 4.37).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains less than 0.5 Endotoxin Unit per ml.

Sterility Complies with the “Sterility Test” (Appendix 10.1).