Pure Steam
[Note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 
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DEFINITION
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 EPA National Primary Drinking Water Regulations, or with drinking water regulations of the European Union or of 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.
and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the EPA National Primary Drinking Water Regulations, or with drinking water regulations of the European Union or of 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. ]
SPECIFIC TESTS
• Total Organic Carbon 643:
The condensate meets the requirement.
643:
The condensate meets the requirement.
• Water Conductivity, Bulk Water 645:
The condensate meets the requirement.
645:
The condensate meets the requirement.
• Bacterial Endotoxins Test 85:
The condensate contains less than 0.25 USP Endotoxin Unit/mL when used in the production of parenterals.
85:
The condensate contains less than 0.25 USP Endotoxin Unit/mL when used in the production of parenterals.
ADDITIONAL REQUIREMENTS
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Antonio Hernandez-Cardoso, M.Sc.
Senior Scientific Liaison (301) 816-8308 |
(GCCA2010) General Chapters - Chemical Analysis |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 5808
Pharmacopeial Forum: Volume No. 31(2) Page 467