usp31nf26s1_m1013, USP Monographs: Pure Steam

Pure Steam

note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes

» 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.

note—Pure 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

—
USP 1,4-Benzoquinone RS

.
USP Endotoxin RS.
USP Sucrose RS

Bacterial endotoxins

— 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— Staff Liaison : Gary E. Ritchie, M.Sc., Scientific Fellow

Expert Committee : (PW05) Pharmaceutical Waters 05

USP31–NF26 Page 3525

Pharmacopeial Forum : Volume No. 31(2) Page 467

Phone Number : 1-301-816-8353