(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.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 50 µg per mL.
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).
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.
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USP35NF30 Page 2489