Bacteriostatic Water for Injection
[noteFor microbiological guidance, see general information chapter Water for Pharmaceutical Purposes
![]() ![]() » Bacteriostatic Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged, containing one or more suitable antimicrobial agents.
[noteUse 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. ]
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.
Sterility
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USP Reference standards
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USP Endotoxin RS
Antimicrobial agent(s)
It meets the requirements under Antimicrobial Effectiveness Testing
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Bacterial endotoxins
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Particulate matter
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pH
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Calcium
To 100 mL add 2 mL of ammonium oxalate TS: no turbidity is produced.
Carbon dioxide
To 25 mL add 25 mL of calcium hydroxide TS: the mixture remains clear.
Sulfate
To 100 mL add 1 mL of barium chloride TS: no turbidity is produced.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 5040
Pharmacopeial Forum: Volume No. 30(4) Page 1315
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