Acepromazine Tablets

General Notices

Action and use

Dopamine receptor antagonist; neuroleptic.

Definition

Acepromazine Tablets contain Acepromazine Maleate.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of acepromazine, C19H22N2OS

92.5 to 107.5% of the stated amount.

Identification

A. To a quantity of the powdered tablets containing the equivalent of 20 mg of acepromazine add 2 mL of water and 3 mL of 2m sodium hydroxide. Extract with two 5 mL quantities of cyclohexane and evaporate to dryness under reduced pressure. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of acepromazine (RSV 01).
B. Complies with the test for identification of phenothiazines, Appendix III A, applying to the plate 1 µL of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing the equivalent of 20 mg of acepromazine with two 5 mL quantities of chloroform. Solution (2) is a solution of acepromazine maleate BPCRS in chloroform containing the equivalent of 0.2% w/v of acepromazine.
C. To a quantity of the powdered tablets containing the equivalent of 5 mg of acepromazine add 2 mL of sulfuric acid. A yellow colour is produced which becomes deep orange on warming for 2 minutes.
D. Dissolve as completely as possible a quantity of the powdered tablets containing the equivalent of 25 mg of acepromazine in a mixture of 3 mL of water and 2 mL of 5m sodium hydroxide and shake with three 3 mL quantities of ether. Add 2 mL of bromine solution to the aqueous solution, warm in a water bath for 10 minutes, heat to boiling and cool. Add 0.25 mL to a solution of 10 mg of resorcinol in 3 mL of sulfuric acid and heat for 15 minutes on a water bath. A bluish black colour develops.

Tests

Related substances

Comply with the test for related substances in phenothiazines, Appendix III A, but using a mixture of 8 volumes of diethylamine, 17 volumes of butan-2-one and 75 volumes of n-hexane as the mobile phase and using the following solutions. For solution (1) shake a quantity of the powdered tablets containing the equivalent of 50 mg of acepromazine with 10 mL of chloroform, filter, evaporate to dryness and dissolve the residue in 5 mL of methanol containing 0.5% v/v of 13.5m ammonia. For solution (2) dilute 1 volume of solution (1) to 100 volumes with methanol containing 0.5% v/v of 13.5m ammonia.

Assay

Weigh and powder 20 tablets. To a quantity of the powder containing the equivalent of 60 mg of acepromazine add 5 mL of water and extract with three or more 50 mL quantities of chloroform or until the chloroform extract is colourless. Evaporate to dryness and dissolve the residue in 15 mL of acetic anhydride. Carry out Method I for non-aqueous titration, Appendix VIII A, using 0.02m perchloric acid VS as titrant and crystal violet solution as indicator. Each mL of 0.02m perchloric acid VS is equivalent to 6.529 mg of C19H22N2OS.

Labelling

The quantity of the active ingredient is stated in terms of the equivalent amount of acepromazine.