Carbinoxamine Maleate Tablets
»Carbinoxamine Maleate Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of C16H19ClN2O·C4H4O4.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Asolution of carbinoxamine maleate (1in 50,000)in dilute sulfuric acid (1in 70)prepared from the Tablets as directed under Salts of Organic Nitrogenous Bases á501ñexhibits an absorbance maximum at 263±2nm.The absorptivity at 263nm is within 7.0%of that of a 1in 50,000solution of USP Carbinoxamine Maleate RSin dilute sulfuric acid (1in 70),similarly measured.
Dissolution á711ñ
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C16H19ClN2O·C4H4O4dissolved from UVabsorbances at the wavelength of maximum absorbance at about 260nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Carbinoxamine Maleate RSin the same medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C16H19ClN2O·C4H4O4is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Place 1Tablet in a 100-mLvolumetric flask,add 10.0mLof water,and shake by mechanical means for 15minutes.Dilute with methanol to volume,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the subsequent filtrate quantitatively and stepwise,if necessary,with a mixture of methanol and water (9:1)to obtain a solution containing about 40µg of carbinoxamine maleate per mL.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Carbinoxamine Maleate RS,in the same medium having a known concentration of about 40µg per mL,in 1-cm cells,at the wavelength of maximum absorbance at about 260nm,with a suitable spectrophotometer,using a mixture of methanol and water (9:1)as the blank.Calculate the quantity,in mg,of C16H19ClN2O·C4H4O4in the Tablet taken by the formula:
(TC/D)(AU/AS),
in which Tis the labeled quantity,in mg,of carbinoxamine maleate in the Tablet,Cis the concentration,in µg per mL,of USP Carbinoxamine Maleate RSin the Standard solution,Dis the concentration,in µg per mL,of carbinoxamine maleate in the solution from the Tablet,based upon the labeled quantity per Tablet and the extent of dilution,and AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.
Assay— Weigh and finely powder not less than 30Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of carbinoxamine maleate,to a separator,add 35mLof water and 3g of sodium bicarbonate,and mix.Extract with five 20-mLportions of chloroform,filtering the extracts through a pledget of cotton.Evaporate the combined chloroform extracts on a steam bath just to dryness,dissolve the residue in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.05Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.05Nperchloric acid is equivalent to 10.17mg 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