» 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.
note—Purified 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.
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