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 or of Japan or with the World Health Organization's Guidelines for Drinking Water Quality. It contains no added substance.
[NoteWater for Injection, whether it is available in bulk or packaged forms, 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. In addition to the Specific Tests, Water for Injection that is packaged for commercial use elsewhere meets the additional requirements for Packaging and Storage and Labeling as indicated under Additional Requirements. ]
[NoteRequired for bulk and packaged forms of Water for Injection. ]
• Bacterial Endotoxins Test 85: Less than 0.25 USP Endotoxin Unit/mL
• Water Conductivity, Bulk Water 645: Meets the requirements
• Total Organic Carbon 643: Meets the requirements
[NoteRequired for packaged forms of Water for Injection. ]
• Packaging and Storage: Where packaged, preserve in unreactive storage containers that are designed to prevent microbial entry.
• Labeling: Where packaged, label the article to state that it contains no antimicrobial or other substance, and that it is not intended for direct parenteral administration.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 5039Pharmacopeial Forum: Volume No. 36(1) Page 144