Purified Water
[Note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes
![]() ![]() 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
![]() ![]() SPECIFIC TESTS
[Note—Required for bulk and packaged forms of Purified Water ]
• Total Organic Carbon
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• Water Conductivity, Bulk Water
![]() ![]() 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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
USP38–NF33 Page 5807
Pharmacopeial Forum: Volume No. 35(2) Page 317
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