Packaging and storage— Preserve in single-dose or multiple-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass,of not larger than 30-mLsize.

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 á71ñ: meets the requirements.

USP Reference standards á11ñ— USP Endotoxin RS.

Antimicrobial agent(s)— It meets the requirements under Antimicrobial Preservatives—Effectiveness á51ñ,and meets the labeled claim for content of the antimicrobial agent(s),as determined by the method set forth under Antimicrobial Agents—Content á341ñ.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.

Particulate matter á788ñ: meets the requirements.

pHá791ñ: between 4.5and 7.0,in a solution containing 0.3mLof saturated potassium chloride solution per 100mLof test specimen.

Calcium— To 100mLadd 2mLof ammonium oxalate TS:no turbidity is produced.

Carbon dioxide— To 25mLadd 25mLof calcium hydroxide TS:the mixture remains clear.

Sulfate— To 100mLadd 1mLof barium chloride TS:no turbidity is produced.

Expert Committee:(PW)Pharmaceutical Waters

USP28–NF23Page 2033

Phone Number:1-301-816-8328