Ergocalciferol Tablets
Action and use
Vitamin D analogue (Vitamin D2).
Definition
Ergocalciferol Tablets contain Ergocalciferol.
Content of ergocalciferol, C28H44O
90.0 to 125.0% of the stated amount.
Identification
Tests
Uniformity of content
Ergocalciferol Tablets comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions, protected from light.
For tablets containing 0.25 mg or less carry out the same procedure but using 2 mL of water, 6 mL of dimethyl sulfoxide and 25 mL of hexane.
8 volumes of pentan-1-ol and 992 volumes of hexane.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0.
Calculate the content of ergocalciferol, C28H44O, in each tablet using the declared content of C28H44O in ergocalciferol BPCRS.
Assay
Use the average of the individual results obtained in the test for Uniformity of content.
Labelling
The label states the equivalent number of IU (International Units) of antirachitic activity (vitamin D) per tablet.
Each μg of ergocalciferol is equivalent to 40 IU of antirachitic activity (vitamin D).
When calciferol tablets are prescribed or demanded, Colecalciferol Tablets or Ergocalciferol Tablets shall be dispensed or supplied.