Sterile Water for Injection
11
[Note—For microbiological guidance, see Water for Pharmaceutical Purposes 1231. ]
1231. ]
Change to read:
(ERR 1-Oct-2014)
DEFINITION
Sterile Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged. It contains no antimicrobial agent or other added substance.
SPECIFIC TESTS
• Oxidizable Substances
Sample:
100 mL
Analysis:
Add 10 mL of 2 N sulfuric acid, and heat to a boil. For Sterile Water for Injection in containers having a fill volume 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
• Particulate Matter in Injections 788:
Meets the requirements
788:
Meets the requirements
• Sterility Tests 71:
Meets the requirements
71:
Meets the requirements
• Bacterial Endotoxins Test 85:
Less than 0.25 USP Endotoxin Unit/mL
85:
Less than 0.25 USP Endotoxin Unit/mL
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose glass or plastic containers of not larger than 1-L size. Glass containers are preferably of Type I or Type II glass.
• Labeling:
Label it to indicate that no antimicrobial or other substance has been added, and that it is not suitable for intravascular injection without first having been made approximately isotonic by the addition of a suitable solute.
Change to read:
• USP Reference Standards 11
(ERR 1-Oct-2014)
USP Endotoxin RS
(ERR 1-Oct-2014)
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 |
| 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 5806
Pharmacopeial Forum: Volume No. 38(3)