Folic Acid Tablets
Action and use
Vitamin B component.
Definition
Folic Acid Tablets contain Folic Acid.
Content of folic acid, C19H19N7O6
90.0 to 110.0% of the stated amount.
Identification
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
20 volumes of 13.5m ammonia, 20 volumes of propan-1-ol and 60 volumes of ethanol (96%).
The principal spot in the chromatogram obtained with solution (1) is similar in position, fluorescence and size to that in the chromatogram obtained with solution (2).
Tests
Hydrolysis products
Carry out the method for liquid chromatography, Appendix III D, using the following solutions protected from light.
In the chromatogram obtained with solution (2) the substances elute in the following order: N-(4-aminobenzoyl)-l-glutamic acid and 4-aminobenzoic acid.
0.05m potassium dihydrogen orthophosphate, adjusted to pH 5.5 with 5m sodium hydroxide.
The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the two peaks is at least 3.0.
In the chromatogram obtained with solution (1):
the areas of the peaks corresponding to 4-aminobenzoic acid and N-(4-aminobenzoyl)-l-glutamic acid are not greater than the areas of the peaks corresponding to 4-aminobenzoic acid and N-(4-aminobenzoyl)-l-glutamic acid in the chromatogram obtained with solution (2).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Folic Acid 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.
7 volumes of acetonitrile and 93 volumes of 0.05m potassium dihydrogen orthophosphate adjusted to pH 6.0 with 5m sodium hydroxide.
Calculate the content of C19H19N7O6 in each tablet using the declared content of C19H19N7O6 in folic acid BPCRS.
Assay
For tablets containing less than 2 mg and/or less than 2% w/w of Folic Acid
Use the average of the individual results determined in the test for Uniformity of content.
For tablets containing 2 mg or more and 2% w/w or more of Folic Acid
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions protected from light.
Calculate the content of C19H19N7O6 in the tablets using the declared content of C19H19N7O6 in folic acid BPCRS.
Storage
Folic Acid Tablets should be protected from light.