Acepromazine Maleate Tablets
»Acepromazine Maleate Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of acepromazine maleate (C19H22N2OS·C4H4O4).
Packaging and storage— Preserve in tight,light-resistant containers,and store at controlled room temperature.
Labeling— Label the Tablets to indicate that they are for veterinary use only.
USP Reference standards á11ñ USP Acepromazine Maleate RS.
NOTE—Throughout the following procedures,protect test or assay specimens,the Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification—
A:Infrared Absorption á197Kñ
Test specimen: To a quantity of powdered Tablets,equivalent to about 20mg of acepromazine maleate,add 2mLof water and 3mLof 2Nsodium hydroxide,and extract with two 5-mLportions of cyclohexane.Combine the cyclohexane extracts,and evaporate to dryness under vacuum,using gentle heat,if necessary.
B: The retention time of the major peak for acepromazine in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assayunder Acepromazine Maleate.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Acepromazine Maleate.
Assay preparation— Transfer not fewer than 10Tablets,accurately counted,to a 200-mLvolumetric flask.Add about 100mLof 0.05Nhydrochloric acid,and sonicate for about 10minutes.Shake by mechanical means for about 30minutes,dilute with 0.05Nhydrochloric acid to volume,and mix.Quantitatively dilute an accurately measured volume of this solution with water to obtain a solution containing about 0.1mg of acepromazine maleate per mL.Pass a portion of this solution through a filter having a 0.5-µm or finer porosity,and use the filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Acepromazine Maleate.Calculate the quantity,in mg,of acepromazine maleate (C19H22N2OS·C4H4O4)in each Tablet taken by the formula:
(LC/D)(rU/rS),
in which Lis the labeled quantity,in mg,of acepromazine maleate in each Tablet;Cis the concentration,in mg per mL,of USP Acepromazine Maleate RSin the Standard preparation;Dis the concentration,in mg per mL,of acepromazine maleate in the Assay preparation,based on the labeled quantity per Tablet,the number of Tablets taken,and the extent of dilution;and rUand rSare the acepromazine peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 16
Pharmacopeial Forum:Volume No.27(3)Page 2494
Phone Number:1-301-816-8178