Water for Injection
[Note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 
1231
. ]
1231. ]
DEFINITION
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.
[Note—Water 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. ]
SPECIFIC TESTS
[Note—Required for bulk and packaged forms of Water for Injection. ]
• Bacterial Endotoxins Test 85:
Less than 0.25 USP Endotoxin Unit/mL
85:
Less than 0.25 USP Endotoxin Unit/mL
• Water Conductivity, Bulk Water 645:
Meets the requirements
645:
Meets the requirements
• Total Organic Carbon 643:
Meets the requirements
643:
Meets the requirements
ADDITIONAL REQUIREMENTS
[Note—Required 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.
') + '&img=../../images/v35300/c11rs116.gif',600,500);)
') + '&img=../../images/v35300/cas-57-50-1.gif',600,500);)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Antonio Hernandez-Cardoso, M.Sc.
Senior Scientific Liaison 1-301-816-8308 |
(GCCA2010) General Chapters - Chemical Analysis |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 5039
Pharmacopeial Forum: Volume No. 36(1) Page 144