(des ip' ra meen hye'' droe klor' ide).
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 2 hours, contains not less than 98.0 percent and not more than 100.5 percent of C18H22N2·HCl.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 30 µg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 251 nm, calculated on the dried basis, do not differ by more than 2.0%.
C: Add about 5 mg to 2 mL of nitric acid on a spot plate: an intense blue color is produced.
D: A 1 in 20 solution in alcohol responds to the tests for Chloride 191.
Loss on drying 731 Dry it in vacuum at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.001%.
Limit of iminodibenzyl
Standard solution Dissolve an accurately weighed quantity of USP Iminodibenzyl RS in alcohol, and dilute quantitatively and stepwise with alcohol to obtain a solution having a concentration of 50 µg per mL. Transfer 1.0 mL of this solution to a low-actinic, 25-mL volumetric flask, add 10 mL of a mixture of equal volumes of hydrochloric acid and alcohol, and mix.
Test solution Transfer 50.0 mg of Desipramine Hydrochloride to a low-actinic, 25-mL volumetric flask, add 10 mL of a mixture of equal volumes of hydrochloric acid and alcohol, and mix.
Procedure To the two flasks containing the Standard solution and the Test solution, and to a third flask containing 10 mL of a mixture of equal volumes of hydrochloric acid and alcohol to provide the blank, add slowly 5 mL of a 0.4% (v/v) solution of furfural in alcohol, mix, then add 5 mL of hydrochloric acid, and allow the flasks to stand in a constant-temperature bath at 25 for 3 hours. 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 565 nm, with a suitable spectrophotometer, using the blank to set the instrument: the absorbance of the solution obtained from the Test solution is not greater than that obtained from the Standard solution (0.1%).
Assay Dissolve about 0.6 g of Desipramine Hydrochloride, previously dried and accurately weighed, in 100 mL of glacial acetic acid, add 10 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically, using a calomel-glass electrode system. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 30.29 mg of C18H22N2·HCl.
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USP35NF30 Page 2825