Nortriptyline Hydrochloride
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C19H21N·HCl 299.84

1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.
10,11-Dihydro-N-methyl-5H-dibenzo[a,d]cycloheptene-D5, -propylamine hydrochloride [894-71-3].
» Nortriptyline Hydrochloride contains not less than 97.0 percent and not more than 101.5 percent of C19H21N·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Solution: 50 mg per mL.
Medium: chloroform.
B: Ultraviolet Absorption 197U
Solution: 10 µg per mL.
Medium: methanol.
Absorptivities at 239 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: It responds to the tests for Chloride 191 when tested as specified for alkaloidal hydrochlorides.
Melting range, Class I 741: between 215 and 220, but the range between beginning and end of melting does not exceed 3.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Chromatographic purity—
Adsorbent: chromatographic silica gel mixture.
Test solution— Transfer about 250 mg of Nortriptyline Hydrochloride, accurately weighed, to a 10-mL volumetric flask. Dissolve in and dilute with methanol to volume, and mix.
Standard solutions— Dissolve an accurately weighed quantity of USP Nortriptyline Hydrochloride RS in methanol, and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution having a known concentration of about 25.0 mg per mL (Standard solution A). Dilute appropriate portions of this solution with methanol to obtain Standard solutions B, C, D, E, and F having known concentrations of 125, 75, 50, 25, and 12.5 µg per mL, respectively. The final concentrations of Standard solutions B, C, D, E, and F represent 0.5%, 0.3%, 0.2%, 0.1%, and 0.05% of Standard solution A concentration, respectively.
Application volume: 5 µL.
Developing solvent system: a mixture of acetonitrile, methanol, and ammonium hydroxide (10:1:1).
Procedure— Apply equal volumes of the Test solution and Standard solutions A, B, C, D, E, and F as directed in Ordinary Impurities 466. Examine the plate under short-wavelength UV light, then spray the plate with Dragendorff's TS, dry the plate with a stream of nitrogen, and then spray with hydrogen peroxide TS: any secondary spot at an RF value of 0.78 relative to the nortriptyline spot in the Test solution is not greater than the principal spot for Standard solution D; any other secondary spot in the Test solution is not more than 0.1%; and the sum of all secondary spots is not more than 0.5%.
Assay— Dissolve about 600 mg of Nortriptyline Hydrochloride, accurately weighed, in 50 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. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 29.98 mg of C19H21N·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3118
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.