Sterile Purified Water
H2O 18.02
[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 boiling. 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.
• 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.
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 1-301-816-8308 |
(GCCA2010) General Chapters - Chemical Analysis |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 5041
Pharmacopeial Forum: Volume No. 35(5) Page 1180