Acepromazine Maleate Tablets
» Acepromazine Maleate Tablets contain not less than 90.0 percent and not more than 110.0 percent 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 11
USP Acepromazine Maleate RS Click to View Structure
[note—Throughout the following procedures, protect test or assay specimens, the USP Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware. ]
A: Infrared Absorption 197K
Test specimen: To a quantity of powdered Tablets, equivalent to about 20 mg of acepromazine maleate, add 2 mL of water and 3 mL of 2 N sodium hydroxide, and extract with two 5-mL portions 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay under Acepromazine Maleate.
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Acepromazine Maleate.
Assay preparation— Transfer not fewer than 10 Tablets, accurately counted, to a 200-mL volumetric flask. Add about 100 mL of 0.05 N hydrochloric acid, and sonicate for about 10 minutes. Shake by mechanical means for about 30 minutes, dilute with 0.05 N hydrochloric acid to volume, and mix. Quantitatively dilute an accurately measured volume of this solution with water to obtain a solution containing about 0.1 mg 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 Procedure in the Assay under 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 L is the labeled quantity, in mg, of acepromazine maleate in each Tablet; C is the concentration, in mg per mL, of USP Acepromazine Maleate RS in the Standard preparation; D is 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 rU and rS are the acepromazine peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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