Sterile Purified Water
H2O 18.02
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[Note—For microbiological guidance, see Water for Pharmaceutical Purposes 1231. ]
1231. ]
H2O 18.02
DEFINITION
Sterile Purified Water is Purified Water sterilized and suitably packaged. It contains no antimicrobial agents. [Note—Do not use Sterile Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection. ]
SPECIFIC TESTS
• Oxidizable Substances
Sample:
100 mL
Analysis:
Add 10 mL of 2 N sulfuric acid, and heat to a boil. For Sterile Purified Water in containers having a fill volume of less than 50 mL, add 0.4 mL of 0.02 M potassium permanganate, and boil for 5 min; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 min. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter.
Acceptance criteria:
The pink color does not completely disappear. Alternatively, perform the test for Total Organic Carbon 643, Sterile Water.
643, Sterile Water.
• Total Organic Carbon, Sterile Water 643:
Meets the requirements. Alternatively, perform the test for Oxidizable Substances.
643:
Meets the requirements. Alternatively, perform the test for Oxidizable Substances.
• Water Conductivity, Sterile Water 645:
Meets the requirements
645:
Meets the requirements
• Sterility Tests 71:
Meets the requirements
71:
Meets the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in suitable tight containers.
• Labeling:
Label it to indicate the method for preparation and to indicate that it is not for parenteral administration.
Add the following:
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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 |
| 71 |
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 5807
Pharmacopeial Forum: Volume No. 38(3)