สารบัญ

Category Pharmaceutic aid (solvent).

      Water for Injection is water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. It is prepared from water that complies with the regulations on water intended for human consumption laid down by the competent authority. It contains no added substance.

(Note Water for Injection is intended for use as a solvent for the preparation of parenteral solutions subject to final sterilization. Use suitable means to minimize growth, or first render the Water for Injection sterile and thereafter protect it from microbial contamination. For parenteral solutions that are prepared under aseptic conditions and are not sterilized by appropriate filtration or in the final container, first render the Water for Injection sterile and, thereafter, protect it from microbial contamination.)

Description Clear, colourless liquid; odourless.

Packaging and storages Water for Injection shall be kept in unreactive storage containers that are designed to prevent microbial entry.

Labelling The label on the container states (1) that it contains no antimicrobial or other substance; (2) that it is not intended for direct parenteral administration.

Total organic carbon Complies with the “Total Organic Carbon” (Appendix 4.36). Alternatively the test method for Oxidizable substances may be performed. To 100 ml, add 10 ml of 1 M sulfuric acid, and heat to boiling. Add 0.20 ml of 0.020 M potassium permanganate, and boil for 5 minutes. The pink colour does not completely disappear.

Water conductivity Complies with the “Water Conductivity” (For Bulk 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.