Carbinoxamine Maleate
(kar'' bin ox' a meen mal' ee ate).
Ethanamine, 2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N,N-dimethyl-, (Z)-2-butenedioate (1:1). 2-[p-Chloro--[2-(dimethylamino)ethoxy]benzyl]pyridine maleate (1:1) [3505-38-2]. » Carbinoxamine Maleate, dried at 105 for 2 hours, contains not less than 98.0 percent and not more than 102.0 percent of C16H19ClN2O·C4H4O4.
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
B:
Ultraviolet Absorption 197U
Solution:
50 µg per mL.
Medium:
methanol.
Absorptivities at 260 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741:
between 116 and 121, determined after drying.
pH 791:
between 4.6 and 5.1, in a solution (1 in 100).
Loss on drying 731
Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281:
not more than 0.1%.
Ordinary impurities 466
Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
a mixture of cyclohexane, chloroform, and diethylamine (75:15:10).
Visualization:
1.
Assay
Dissolve about 400 mg of Carbinoxamine Maleate, previously dried and accurately weighed, in 50 mL of glacial acetic acid, add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 20.34 mg of C16H19ClN2O·C4H4O4.
Auxiliary Information
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USP35NF30 Page 2489
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