Desipramine Hydrochloride
;)
5H-Dibenz[b,f]azepine-5-propanamine,10,11-dihydro-N-methyl-,monohydrochloride.
10,11-Dihydro-5-[3-(methylamino)propyl]-5H-dibenz[b,f]azepine monohydrochloride [58-28-6].
»Desipramine Hydrochloride,dried in vacuum at 105
for 2hours,contains not less than 98.0percent and not more than 100.5percent of C18H22N2·HCl.
for 2hours,contains not less than 98.0percent and not more than 100.5percent of C18H22N2·HCl.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Mñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
30µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 251nm,calculated on the dried basis,do not differ by more than 2.0%.
C:
Add about 5mg to 2mLof nitric acid on a spot plate:an intense blue color is produced.
D:
A1in 20solution in alcohol responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it in vacuum at 105for 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:
0.001%.
Limit of iminodibenzyl—
Standard solution—
Dissolve an accurately weighed quantity of USP Iminodibenzyl RSin alcohol,and dilute quantitatively and stepwise with alcohol to obtain a solution having a concentration of 50µg per mL.Transfer 1.0mLof this solution to a low-actinic,25-mLvolumetric flask,add 10mLof a mixture of equal volumes of hydrochloric acid and alcohol,and mix.
Test solution—
Transfer 50.0mg of Desipramine Hydrochloride to a low-actinic,25-mLvolumetric flask,add 10mLof a mixture of equal volumes of hydrochloric acid and alcohol,and mix.
Procedure—
To the two flasks containing the Standard solutionand the Test solution,and to a third flask containing 10mLof a mixture of equal volumes of hydrochloric acid and alcohol to provide the blank,add slowly 5mLof a 0.4%(v/v)solution of furfural in alcohol,mix,then add 5mLof hydrochloric acid,and allow the flasks to stand in a constant-temperature bath at 25for 3hours.Dilute each flask with a mixture of equal volumes of hydrochloric acid and alcohol to volume,and mix.Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 565nm,with a suitable spectrophotometer,using the blank to set the instrument:the absorbance of the solution obtained from the Test solutionis not greater than that obtained from the Standard solution(0.1%).
for 3hours.Dilute each flask with a mixture of equal volumes of hydrochloric acid and alcohol to volume,and mix.Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 565nm,with a suitable spectrophotometer,using the blank to set the instrument:the absorbance of the solution obtained from the Test solutionis not greater than that obtained from the Standard solution(0.1%).
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 0.6g of Desipramine Hydrochloride,previously dried and accurately weighed,in 100mLof glacial acetic acid,add 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically,using a calomel-glass electrode system.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 30.29mg of C18H22N2·HCl.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 581
Phone Number:1-301-816-8165