Chlorpheniramine Maleate
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C16H19ClN2·C4H4O4 390.86

2-Pyridinepropanamine,g-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2-butenedioate (1:1).
2-[p-Chloro-a-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1) [113-92-8].
»Chlorpheniramine Maleate contains not less than 98.0percent and not more than 100.5percent of C16H19ClN2·C4H4O4,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification, Infrared Absorption á197Kñ.
Melting range á741ñ: between 130and 135.
Loss on drying á731ñ Dry it at 105for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ: not more than 0.2%.
Related compounds—
Test preparation— Dissolve about 200mg of Chlorpheniramine Maleate in 5mLof methylene chloride,and mix.
Chromatographic system (see Chromatography á621ñ) The gas chromatograph is equipped with a flame-ionization detector and a 1.2-m ×4-mm glass column containing 3%phase G3on support S1AB.The column temperature is maintained at about 190,and the injection port and detector temperatures are both maintained at about 250.The carrier gas is dry helium,flowing at a rate adjusted to obtain a retention time of 4to 5minutes for the main peak.Chromatograph the Test preparation,record the chromatogram,and determine the peak area as directed for Procedure:the tailing factor for the chlorpheniramine maleate peak is not more than 1.8.
Procedure— Inject a volume (about 1µL)of the Test preparationinto the chromatograph.Record the chromatogram for a total time of not less than twice the retention time of the chlorpheniramine peak,and measure the areas of the peaks.The total relative area of all extraneous peaks (except that of the solvent peak and maleic acid,if observed)does not exceed 2.0%.
Organic volatile impurities,Method IVá467ñ: meets the requirements.
Assay— Dissolve about 500mg of Chlorpheniramine Maleate,accurately weighed,in 20mLof glacial acetic acid.Add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 19.54mg of C16H19ClN2·C4H4O4.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 448
Pharmacopeial Forum:Volume No.29(5)Page 1439
Phone Number:1-301-816-8379