Water for Injection
noteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231.
» 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 complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations or with the drinking water regulations of the European Union, Japan, or with the World Health Organization's Guidelines for Drinking Water Quality. It contains no added substance.
noteWater for Injection is intended for use in the preparation of parenteral solutions. Where used for the preparation of parenteral solutions subject to final sterilization, use suitable means to minimize microbial 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. The tests for Total organic carbon and Water conductivity apply to Water for Injection produced on site for use in manufacturing. Water for Injection packaged in bulk for commercial use elsewhere meets the requirement of the test for Bacterial endotoxins as indicated below and the requirements of all the tests under Sterile Purified Water, except Labeling.
Bacterial endotoxins 85 It contains less than 0.25 USP Endotoxin Unit per mL.
Total organic carbon 643: meets the requirements.
Water conductivity 645: meets the requirements.
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USP32NF27 Page 3870Pharmacopeial Forum: Volume No. 31(2) Page 466