Purified Water
H2O 18.02
[Note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 
1231
. ]
1231. ]
H2O 18.02
DEFINITION
Purified Water is water obtained by a suitable process. 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—Purified Water whether it is available in bulk or packaged forms, is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified (see 8.230. Water under 8. Terms and Definitions in the General Notices and Requirements). Where used for sterile dosage forms, other than for parenteral administration, process the article to meet the requirements under Sterility Tests 71, or first render the Purified Water sterile and thereafter protect it from microbial contamination. Do not use Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection. In addition to the Specific Tests, Purified Water that is packaged for commercial use elsewhere meets the additional requirements for Packaging and Storage and Labeling as indicated under Additional Requirements. ]
71, or first render the Purified Water sterile and thereafter protect it from microbial contamination. Do not use Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection. In addition to the Specific Tests, Purified Water 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 Purified Water ]
• Total Organic Carbon 643:
Meets the requirements
643:
Meets the requirements
• Water Conductivity, Bulk Water 645:
Meets the requirements
645:
Meets the requirements
ADDITIONAL REQUIREMENTS
[Note—Required for packaged forms of Purified Water ]
• Packaging and Storage:
Where packaged, preserve in unreactive storage containers that are designed to prevent microbial entry.
• Labeling:
Where packaged, label it to indicate the method of preparation and that it is not intended for 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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 5041
Pharmacopeial Forum: Volume No. 35(2) Page 317