Purified Water
H2O
18.02
NOTEFor microbiological guidance,see general information chapter Water for Pharmaceutical Purposes á1231ñ.
»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 comparable regulations of the European Union or Japan.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 Waterin Ingredients and Processesand in Tests and Assaysunder General Notices and Requirements).Where used for sterile dosage forms,other than for parenteral administration,process the article to meet the requirements underSterility Tests á71ñ,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 carbonand 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 á71ñ.
USP Reference standards á11ñ
USP1,4-Benzoquinone RS.USP Sucrose RS.
Total organic carbon á643ñ:
meets the requirements.
Water conductivity á645ñ:
meets the requirements.
Auxiliary Information
Staff Liaison:Francis P.Barletta
Expert Committee:(PW)Pharmaceutical Waters
USP28NF23Page 2035
Pharmacopeial Forum:Volume No.30(4)Page 1316
Phone Number:1-301-816-8328
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