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Bacteriostatic Water for Injection
NOTE—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 1231.
» 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.
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 71: meets the requirements.
Antimicrobial agent(s)— It meets the requirements under Antimicrobial Effectiveness Testing 51, and meets the labeled claim for content of the antimicrobial agent(s), as determined by the method set forth under Antimicrobial Agents—Content 341.
Bacterial endotoxins 85 It contains less than 0.5 USP Endotoxin Unit per mL.
Particulate matter 788: meets the requirements.
pH 791: between 4.5 and 7.0, in a solution containing 0.3 mL of saturated potassium chloride solution per 100 mL of test specimen.
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— Staff Liaison : Gary E. Ritchie, M.Sc., Scientific Fellow
Expert Committee : (PW05) Pharmaceutical Waters 05
USP29–NF24 Page 2263
Pharmacopeial Forum : Volume No. 30(4) Page 1315
Phone Number : 1-301-816-8353