Carbinoxamine Maleate
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Ethanamine,2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N,N-dimethyl-,(Z)-2-butenedioate (1:1).
2-[p-Chloro-a-[2-(dimethylamino)ethoxy]benzyl]pyridine maleate (1:1) [3505-38-2].
»Carbinoxamine Maleate,dried at 105
for 2hours,contains not less than 98.0percent and not more than 102.0percent of C16H19ClN2O·C4H4O4.
for 2hours,contains not less than 98.0percent and not more than 102.0percent of C16H19ClN2O·C4H4O4.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Mñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
50µg per mL.
Medium:
methanol.
Absorptivities at 260nm,calculated on the dried basis,do not differ by more than 3.0%.
pHá791ñ:
between 4.6and 5.1,in a solution (1in 100).
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
a mixture of cyclohexane,chloroform,and diethylamine (75:15:10).
Visualization:
1.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 400mg of Carbinoxamine Maleate,previously dried and accurately weighed,in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 20.34mg of C16H19ClN2O·C4H4O4.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 348
Phone Number:1-301-816-8379