[NoteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231. ]
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.
[NotePurified 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. ]
[NoteRequired for bulk and packaged forms of Purified Water ]
• Total Organic Carbon 643: Meets the requirements
• Water Conductivity, Bulk Water 645: Meets the requirements
[NoteRequired 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.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 5041Pharmacopeial Forum: Volume No. 35(2) Page 317