Colecalciferol Tablets
Action and use
Vitamin D analogue (Vitamin D3).
Definition
Colecalciferol Tablets contain Colecalciferol.
Content of colecalciferol, C27H44O
90.0 to 125.0% of the stated amount.
Identification
Tests
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Colecalciferol comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure in subdued light and in low-actinic glassware. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
8 volumes of pentan-1-ol and 992 volumes of hexane.
When the chromatograms are recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol.
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. If necessary, adjust the proportions of the constituents and the flow rate of the mobile phase to obtain this resolution.
Calculate the content of colecalciferol, C27H44O, in each tablet using the declared content of C27H44O in colecalciferol BPCRS.
Assay
For tablets containing less than 2 mg and/or 2% w/w of colecalciferolUse the average of the 10 individual results obtained in the test for Uniformity of content.
For tablets containing 2 mg or more, or 2% w/w or more of colecalciferolCarry out the method for liquid chromatography, Appendix III D, using the following solutions. Carry out the following procedure in subdued light and in low-actinic glassware.
The chromatographic procedure described under Uniformity of content may be used
When the chromatogram is recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol.
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 colecalciferol, C27H44O, in the tablets using the declared content of C27H44O in colecalciferol BPCRS.
STORAGE
Colecalciferol tablets should be protected from light and moisture.
Labelling
The label states the equivalent number of IU (units) of antirachitic activity (vitamin D) per tablet.
Each µg of Colecalciferol is equivalent to 40 IU of antirachitic activity (vitamin D).