Cyproheptadine Hydrochloride
;)
Piperidine,4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methyl-,hydrochloride,sesquihydrate.
4-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride sesquihydrate [41354-29-4].
Anhydrous 323.87 [969-33-5].
»Cyproheptadine Hydrochloride contains not less than 98.5percent and not more than 100.5percent of C21H21N·HCl,calculated on the anhydrous basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
16µg per mL.
Medium:
alcohol.
Absorptivities at 286nm do not differ by more than 3.0%.
C:
Dissolve 100mg of Cyproheptadine Hydrochloride in 10mLof methanol.Place 1drop of the solution on a filter paper,dry,and view under short-wavelength UVlight:a bright blue fluorescence is observed.
Acidity—
Dissolve 1.0g of Cyproheptadine Hydrochloride in 25mLof methanol,add methyl red TS,and titrate with 0.10Nsodium hydroxide:not more than 0.15mLis required (0.05%as HCl).
Water,Method Iá921ñ:
between 7.0%and 9.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.003%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 650mg of Cyproheptadine Hydrochloride,accurately weighed,in 50mLof glacial acetic acid,heating to dissolve.Cool,add 10mLof mercuric acetate TS,0.5mLof acetic anhydride,and 1drop of crystal violet 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 32.39mg of C21H21N·HCl.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 564
Pharmacopeial Forum:Volume No.27(2)Page 2136
Phone Number:1-301-816-8379