Tocainide Hydrochloride
;)
Propanamide,2-amino-N-(2,6-dimethylphenyl)-,hydrochloride,(±)-.
(±)-2-Amino-2¢,6¢-propionoxylidide hydrochloride.
»Tocainide Hydrochloride contains not less than 98.0percent and not more than 101.0percent of C11H16N2O·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
It responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.002%.
Chromatographic purity—
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture coating on a thin-layer chromatographic plate,previously washed with methanol.
Test solution:
100mg per mL,in methanol.
Standard solutions:
1.0,0.5,0.25,and 0.1mg per mLin methanol to obtain Standard solutions A,B,C,and D,respectively.
Application volume:
20µL.
Developing solvent system:
a freshly prepared mixture of toluene and alcohol (4:1)in a paper-lined equilibrated tank in an atmosphere of ammonia vapors.
Procedure—
Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñ.Examine the plate under short-wavelength UVlight.Expose the plate to iodine vapors,and observe again under white light:the chromatograms show principal spots at about the same RFvalue.Estimate the concentration of any spot observed in the chromatogram of the Test solution,other than the principal spot and that observed at the origin (which may appear because of the presence of ammonium chloride),by comparison with the principal spots in the chromatograms of Standard solutions B,C,and D:the intensity of any secondary spot is not greater than that of the principal spot obtained from Standard solution B(0.5%),and the sum of all secondary spots is not greater than the intensity of the principal spot obtained from Standard solution A(1.0%).
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 180mg of Tocainide Hydrochloride,accurately weighed,in about 40mLof glacial acetic acid and 15mLof a 6in 100solution of mercuric acetate in glacial acetic acid,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically,using a platinum ring electrode and a sleeve-type calomel electrode containing 0.1Nlithium perchlorate in acetic anhydride (see Titrimetry á541ñ).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 22.87mg of C11H16N2O·HCl.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1944
Phone Number:1-301-816-8305