Methadone Hydrochloride
;)
3-Heptanone,6-(dimethylamino)-4,4-diphenyl-,hydrochloride.
6-(Dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride [1095-90-5].
»Methadone Hydrochloride contains not less than 98.5percent and not more than 100.5percent of C21H27NO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:Infrared Absorption á197Kñ.
B:
Asolution of it responds to the tests for Chloride á191ñ.
pHá791ñ:
between 4.5and 6.5,in a solution (1in 100).
Loss on drying á731ñ—
Dry about 500mg,accurately weighed,at 105for 1hour:it loses not more than 0.3%of its weight.
for 1hour:it loses not more than 0.3%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of methanol and ammonium hydroxide (100:1.5).
Visualization:
3.
Limits—
The sum of the intensities of all secondary spots obtained from the Test solutioncorresponds to not more than 1.0%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 500mg of Methadone Hydrochloride,accurately weighed,in a mixture of 10mLof glacial acetic acid and 10mLof mercuric acetate TS,warming slightly if necessary to effect solution.Cool the solution to room temperature,add 10mLof dioxane,then add crystal violet TS,and titrate rapidly with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 34.59mg of C21H27NO·HCl.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1233
Pharmacopeial Forum:Volume No.29(6)Page 1929
Phone Number:1-301-816-8139