Lidocaine Ointment
»Lidocaine Ointment is Lidocaine in a suitable hydrophilic ointment base.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of lidocaine (C14H22N2O).
Packaging and storage— Preserve in tight containers.
Identification— Stir a quantity of Ointment,equivalent to about 300mg of lidocaine,with 20mLof water,transfer to a separator,and extract with two 30-mLportions of solvent hexane.Wash the combined hexane extracts with 10mLof water,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.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
Assay— Proceed with Ointment as directed in the Assayunder Lidocaine Hydrochloride Jelly.Each mLof 0.01Nsulfuric acid is equivalent to 2.343mg of C14H22N2O.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1129
Phone Number:1-301-816-8379