Lidocaine Oral Topical Solution, chemical structure, molecular formula, Reference Standards

Lidocaine Oral Topical Solution

»Lidocaine Oral Topical Solution contains not less than 95.0percent and not more than 105.0percent of the labeled amount of lidocaine (C14H22N2O).It contains a suitable flavor.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Lidocaine RS.

Identification— Transfer a quantity of Oral Topical Solution,equivalent to about 250mg of lidocaine,to a separator with 20mLof water,and extract with 20mLof chloroform.Wash the chloroform extract with 20mLof water,and evaporate the chloroform extract with the aid of a current of warm air.Dissolve the residue in hexane,evaporate with the aid of a current of warm air,and dry the residue in vacuum over silica gel for 24hours:the crystalline precipitate so obtained responds to Identificationtest Aunder Lidocaine.

Assay— Transfer an accurately measured volume of Oral Topical Solution,equivalent to about 150mg of lidocaine,to a 125-mLconical flask,and protect from atmospheric moisture with a stopper fitted with a tube containing silica gel.Add 20mLof glacial acetic acid and 2drops of crystal violet TS.Titrate immediately with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 23.43mg of C14H22N2O.

Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1130

Phone Number:1-301-816-8379