Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.Injection may be packaged in 50-mLmultiple-dose containers.

Labeling— Injections that are of such concentration that they are not intended for direct injection into tissues are labeled to indicate that they are to be diluted prior to administration.

USP Reference standards á11ñ— USP Endotoxin RS.USP Lidocaine RS.

Identification— Place in a separator a volume of Injection equivalent to about 300mg of lidocaine hydrochloride,and extract with four 15-mLportions of chloroform,discarding the chloroform extracts.Add 2mLof 2Nsodium hydroxide to the aqueous solution remaining in the separator,and extract with four 15-mLportions of chloroform.Combine the chloroform extracts,and evaporate with the aid of a current of warm air to dryness.Dissolve the crystals so obtained in solvent hexane,evaporate with the aid of warm air,and dry the residue in vacuum over silica gel for 24hours:the residue so obtained responds to Identificationtest Aunder Lidocaine.

Bacterial endotoxins á85ñ— It contains not more than 1.1USP Endotoxin Units per mg of lidocaine hydrochloride.

pHá791ñ: between 5.0and 7.0.

Particulate matter á788ñ: meets the requirements for small-volume injections.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Proceed with Injection as directed in the Assay for lidocaine hydrochlorideunder Lidocaine Hydrochloride and Epinephrine Injection.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1130

Phone Number:1-301-816-8379