[noteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231. ]
» Pure Steam is water that has been heated above 100 and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application.
[notePure Steam is intended for use where the steam or its condensate comes in contact with the article or the preparation. Pure Steam quality is difficult to assess in its vapor state; therefore the attributes of its condensate are used to test its quality. The process used to create and collect the condensate for analysis must not adversely impact these quality attributes. ]
USP Reference standards 11
USP Endotoxin RS
Bacterial endotoxins 85 The condensate contains less than 0.25 USP Endotoxin Unit per mL (when used in the production of parenterals).
Total organic carbon 643: the condensate meets the requirement.
Water conductivity 645: the condensate meets the requirement.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 5042Pharmacopeial Forum: Volume No. 31(2) Page 467