Mepivacaine Hydrochloride
;)
2-Piperidinecarboxamide,N-(2,6-dimethylphenyl)-1-methyl-,monohydrochloride,(±)-.
(±)-1-Methyl-2¢,6¢-pipecoloxylidide monohydrochloride [1722-62-9].
»Mepivacaine Hydrochloride contains not less than 98.0percent and not more than 102.0percent of C15H22N2O·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Dissolve about 250mg in 10mLof water,render slightly alkaline with sodium carbonate TS,extract the precipitate with ether,evaporate the ether extract on a steam bath to dryness,and dry the residue in vacuum at 60
for 1hour:the mepivacaine so obtained melts between 149and 153.
for 1hour:the mepivacaine so obtained melts between 149and 153.
C:
Asolution (1in 100)responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105for 4hours:it loses not more than 1.0%of its weight.
for 4hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Chromatographic purity—
Mix about 500mg with 10mLof water to obtain a test solution.Inject about 1µLof this solution into a suitable gas chromatograph (see Chromatography á621ñ),equipped with a flame-ionization detector.Under typical conditions,the instrument contains a 1.8-m ×4-mm glass column packed with 3percent phase G19on packing S1A.The column is maintained at about 230,and dry helium,flowing at the rate of about 40mLper minute,is used as the carrier gas.Similarly inject about 1µLof a Standard solution of USP Mepivacaine Hydrochloride RSin water having a concentration of about 5mg per mL.Locate the mepivacaine peak in each chromatogram.The total area of all extraneous peaks (except that of the solvent peak)recorded for the test solution,over a time span of not less than 1.3×the retention time for mepivacaine,relative to the total area of all peaks does not exceed 0.4%.
,and dry helium,flowing at the rate of about 40mLper minute,is used as the carrier gas.Similarly inject about 1µLof a Standard solution of USP Mepivacaine Hydrochloride RSin water having a concentration of about 5mg per mL.Locate the mepivacaine peak in each chromatogram.The total area of all extraneous peaks (except that of the solvent peak)recorded for the test solution,over a time span of not less than 1.3×the retention time for mepivacaine,relative to the total area of all peaks does not exceed 0.4%.
Assay—
Transfer about 550mg of Mepivacaine Hydrochloride,accurately weighed,to a 200-mLbeaker,and dissolve in 50mLof glacial acetic acid,heating if necessary.Add 10mLof mercuric acetate TSand 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 28.28mg of C15H22N2O·HCl.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1212
Pharmacopeial Forum:Volume No.29(5)Page 1533
Phone Number:1-301-816-8379