Water for Injection
NOTEFor microbiological guidance,see general information chapter Water for Pharmaceutical Purposes á1231ñ.
»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 comparable regulations of the European Union or Japan.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 carbonand 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 endotoxinsas indicated below and the requirements of all the tests under Sterile Purified Water,except Labeling.
Bacterial endotoxins á85ñ It contains not more than 0.25USP Endotoxin Unit per mL.
Total organic carbon á643ñ: meets the requirements.
Water conductivity á645ñ: meets the requirements.
Auxiliary Information Staff Liaison:Francis P.Barletta
Expert Committee:(PW)Pharmaceutical Waters
USP28NF23Page 2033Pharmacopeial Forum:Volume No.30(5)Page 1650