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, Japan, or with the World Health Organization's Guidelines for Drinking Water Quality. It contains no added substance.
notePurified Water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified (see Water in Ingredients and Processes and in Tests and Assays under 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. The tests for Total organic carbon and Conductivity apply to Purified Water produced on site for use as an ingredient of official preparations and in tests and assays. Purified Water packaged in bulk for commercial use elsewhere meets the requirements of all of the tests under Sterile Purified Water, except Labeling and Sterility 71.
Total organic carbon 643: meets the requirements.
Water conductivity 645: meets the requirements.
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USP32NF27 Page 3872Pharmacopeial Forum: Volume No. 31(2) Page 467