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Category Irrigation solution

      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.

Description Clear, colourless liquid; odourless.

Packaging and storage Sterile Water for Irrigation shall be kept in single-dose glass containers, preferably of Type I or Type II glass, or plastic containers. The container may contain a volume of more than 1 litre, and may be designed to empty rapidly.

Labelling The label on the container states (1) that no antimicrobial or other substance has been added; (2) the prominent designations “For irrigation only” and “Not for injection”.

Oxidizable substances To 100 ml add 10 ml of 1 M sulfuric acid, and heat to boiling. For Sterile Water for Irrigation 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 0.25 Endotoxin Unit per ml.

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