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.
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.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 2073
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.