Acenocoumarol Tablets
Action and use
Vitamin K epoxide reductase inhibitor; oral anticoagulant.
Definition
Acenocoumarol Tablets contain Acenocoumarol.
Content of acenocoumarol, C19H15NO6
92.5 to 107.5% of the stated amount.
Identification
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
20 volumes of glacial acetic acid, 50 volumes of chloroform and 50 volumes of cyclohexane.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Acenocoumarol comply with the requirements stated under Tablets using the following method of analysis. Finely crush one tablet, add 30 mL of methanol, stir the mixture for 30 minutes and filter through sintered glass, washing the residue with three 15 mL quantities of methanol. To the combined filtrate and washings add 10 mL of 1m hydrochloric acid and sufficient methanol to produce 100 mL. If necessary dilute further with a solvent prepared by diluting 1 volume of 1m hydrochloric acid to 10 volumes with methanol to produce a solution containing about 0.001% w/v of Acenocoumarol. Measure the absorbance of the resulting solution at the maximum at 306 nm, Appendix II B. Calculate the content of C19H15NO6 taking 521 as the value of A (1%, 1 cm) at the maximum at 306 nm.
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 1 mg of Acenocoumarol add 30 mL of methanol, stir the mixture for 30 minutes and filter through sintered glass, washing the residue with three 15 mL quantities of methanol. To the combined filtrate and washings add 10 mL of 1m hydrochloric acid and sufficient methanol to produce 100 mL and measure the absorbance of the resulting solution at the maximum at 306 nm, Appendix II B. Calculate the content of C19H15NO6 taking 521 as the value of A (1%, 1 cm) at the maximum at 306 nm.