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.

USP Reference standards 11—
USP Endotoxin RS.

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.

Expert Committee : (PW05) Pharmaceutical Waters 05

USP31–NF26 Page 3523

Phone Number : 1-301-816-8353