Phytomenadione Tablets
Action and use
Vitamin K analogue.
Definition
Phytomenadione Tablets contain Phytomenadione.
Content of phytomenadione, C31H46O2
90.0 to 110.0% of the stated amount.
Identification
Shake a quantity of the powdered tablets containing 50 mg of Phytomenadione with 50 mL of absolute ethanol for 1 hour, allow to stand and dilute 5 mL of the clear supernatant liquid to 50 mL with absolute ethanol. The light absorption of the resulting solution, Appendix II B, in the range 230 to 350 nm exhibits a maximum at 328 nm and a minimum at 292 nm. Dilute a suitable volume of the solution with sufficient absolute ethanol to produce a solution containing 0.001% w/v of Phytomenadione. The light absorption of this solution, in the range 230 to 350 nm, exhibits maxima at 245, 249, 263 and 271 nm and minima at 256 nm and 266 nm.
Tests
Disintegration
The requirement for Disintegration does not apply to Phytomenadione Tablets.
Menadione
Carry out the following procedure in subdued light. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
1 volume of methanol, 20 volumes of ether and 80 volumes of cyclohexane.
Any secondary spot corresponding to menadione in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1%).
Assay
Weigh and powder 20 tablets. Carry out the following procedure in subdued light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
5 volumes of water and 95 volumes of ethanol (96%).
Calculate the content of C31H46O2 in the tablets using the declared content of C31H46O2 in phytomenadione BPCRS.
Labelling
The label states that the tablets should be chewed before swallowing or allowed to dissolve slowly in the mouth.
When vitamin K1 tablets are prescribed or demanded, Phytomenadione Tablets shall be dispensed or supplied.