Procainamide Tablets
Action and use
Class I antiarrhythmic.
Definition
Procainamide Tablets contain Procainamide Hydrochloride.
Content of procainamide hydrochloride, C13H21N3O,HCl
95.0 to 105.0% of the stated amount.
Identification
Related substances
Comply with the test described under Procainamide Injection using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 0.4 g of Procainamide Hydrochloride with 20 mL of methanol (90%) for 15 minutes and filter. For solution (2) dilute 1 volume of solution (1) to 100 volumes with methanol.
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 0.5 g of Procainamide Hydrochloride in a stoppered flask add 100 mL of 6m hydrochloric acid, shake for 15 minutes and titrate with 0.1m sodium nitrite VS, using ferrocyphen solution as indicator, until a violet colour is produced that is stable for not less than 3 minutes. Repeat the operation without the powdered tablets. The difference between the titrations represents the amount of sodium nitrite required. Each mL of 0.1m sodium nitrite VS is equivalent to 27.18 mg of C13H21N3O,HCl.