Proposed For Comment Version 0.2
[Note—For 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.
[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 12.190. Water under 8. Terms and Definitions in the General Notices). 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.]
[Note—Required for bulk and packaged forms of Purified Water]
• Total Organic Carbon <643>: Meets the requirements
• Water Conductivity, Bulk Water <645>: Meets the 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.
• USP reference standards <11>