Bacteriostatic Water for Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 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.]
2 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〉
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〉
Sterility Tests 〈71〉: Meets the requirements
Particulate Matter in Injections 〈788〉: Meets the requirements
Bacterial Endotoxins Test 〈85〉: Less than 0.5 USP Endotoxin Unit/mL
3 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.
