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Protriptyline Hydrochloride
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C19H21N·HCl 299.84

5H-Dibenzo[a,d]cycloheptene-5-propanamine, N-methyl-, hydrochloride.
N-Methyl-5H-dibenzo[a,d]cycloheptene-5-propylamine hydrochloride [1225-55-4].
» Protriptyline Hydrochloride contains not less than 99.0 percent and not more than 101.0 percent of C19H21N·HCl, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
Solution: 10 µg per mL.
Medium: 0.1 N methanolic hydrochloric acid.
Absorptivities at 292 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: It responds to the test for Chloride 191, when tested as specified for alkaloidal hydrochlorides.
D: Its X-ray diffraction pattern (see X-ray Diffraction 941) conforms to that of USP Protriptyline Hydrochloride RS.
pH 791: between 5.0 and 6.5, in a solution (1 in 100).
Loss on drying 731— Dry it at a pressure below 5 mm of mercury at 60 to constant weight: it loses not more than 0.3% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.001%.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 700 mg of Protriptyline Hydrochloride, accurately weighed, to a 125-mL conical flask, and dissolve in 30 mL of glacial acetic acid. Add crystal violet TS and 10 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. 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— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1855
Phone Number : 1-301-816-8330