Bacteriostatic Water for Injection
[Note—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 
1231
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1231. ]
DEFINITION
Bacteriostatic Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged, containing one or more suitable antimicrobial agents.
[Note—Use Bacteriostatic Water for Injection with due regard for the compatibility of the antimicrobial agent or agents it contains with the particular medicinal substance that is to be dissolved or diluted. ]
SPECIFIC TESTS
• Calcium
Sample:
100 mL
Analysis:
Add 2 mL of ammonium oxalate TS to the Sample.
Acceptance criteria:
No turbidity is produced.
• Carbon Dioxide
Sample:
25 mL
Analysis:
Add 25 mL of calcium hydroxide TS to the Sample.
Acceptance criteria:
The mixture remains clear.
• Sulfate
Sample:
100 mL
Analysis:
Add 1 mL of barium chloride TS to the Sample.
Acceptance criteria:
No turbidity is produced.
• pH 791
791
Sample:
To 100 mL of Bacteriostatic Water for Injection add 0.3 mL of saturated potassium chloride solution.
Acceptance criteria:
4.5–7.0
• Antimicrobial Agent(s):
Meets the requirements in Antimicrobial Effectiveness Testing 51, and meets the labeled claim for content of the antimicrobial agent(s), as determined by the method set forth in Antimicrobial Agents—Content 341
51, and meets the labeled claim for content of the antimicrobial agent(s), as determined by the method set forth in Antimicrobial Agents—Content 341
• Sterility Tests 71:
Meets the requirements
71:
Meets the requirements
• Particulate Matter in Injections 788:
Meets the requirements
788:
Meets the requirements
• Bacterial Endotoxins Test 85:
Less than 0.5 USP Endotoxin Unit/mL
85:
Less than 0.5 USP Endotoxin Unit/mL
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose or multiple-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass, of not larger than 30-mL size.
• Labeling:
Label it to indicate the name(s) and proportion(s) of the added antimicrobial agent(s). Label it also to include the statement “Not For Use In Newborns”, in boldface capital letters on the label immediately under the official name, printed in a contrasting color, preferably red. Alternatively, the statement may be placed prominently elsewhere on the label if the statement is enclosed within a box.
• USP Reference Standards 11
11
USP Endotoxin RS
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. 30(4) Page 1315