Protriptyline Hydrochloride
;)
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 99.0percent and not more than 101.0percent of C19H21N·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Mñ.
Solution:
10µg per mL.
Medium:
0.1Nmethanolic hydrochloric acid.
Absorptivities at 292nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
It responds to the test for Chloride á191ñ,when tested as specified for alkaloidal hydrochlorides.
D:
Its X-ray diffraction pattern (see X-ray Diffraction á941ñ)conforms to that of USP Protriptyline Hydrochloride RS.
pHá791ñ:
between 5.0and 6.5,in a solution (1in 100).
Loss on drying á731ñ—
Dry it at a pressure below 5mm of mercury at 60
to constant weight:it loses not more than 0.3%of its weight.
to constant weight:it loses not more than 0.3%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 700mg of Protriptyline Hydrochloride,accurately weighed,to a 125-mLconical flask,and dissolve in 30mLof glacial acetic acid.Add crystal violet TSand 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 29.98mg of C19H21N·HCl.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1669
Phone Number:1-301-816-8165