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Category Pharmaceutic aid (solvent).

      Sterile Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agent(s) or other added substance.

Description Clear, colourless liquid; odourless.

Packaging and storage Sterile Water for Injection shall be kept in glass containers, preferably of Type I or Type II glass, or plastic containers, of not larger than 1-litre size.

Labelling The label on the container states (1) that no antimicrobial or other substance has been added; (2) that it is not suitable for intravascular injection without first having been made approximately isotonic by the addition of a suitable solute.

Oxidizable substances To 100 ml add 10 ml of 1 M sulfuric acid, and heat to boiling. For Sterile Water for Injection 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).

Particulate matter Complies with the requirements described under “Particulate Matter in Injections” (Small-volume Injection, Appendix 4.27).

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).