Ferrous Fumarate Tablets
Definition
Ferrous Fumarate Tablets contain Ferrous Fumarate.
Content of ferrous iron, Fe(II)
90.0 to 105.0% of the stated amount.
Identification
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
After 45 minutes withdraw a sample of 100 mL of the medium and filter. Titrate the filtrate with 0.01m ammonium cerium(iv) sulfate VS using ferroin solution as indicator.
Calculate the total content of Fe(ii) in the medium taking each mL of 0.01m ammonium cerium(iv) sulfate VS to be equivalent to 0.5585 mg of Fe(ii).
Ferric iron
In a flask with a ground-glass stopper dissolve a quantity of the powder prepared for the Assay containing 1.5 g of ferrous fumarate in a mixture of 10 mL of hydrochloric acid and 100 mL of water by heating rapidly to boiling. Boil for 15 seconds. Cool rapidly, add 3 g of potassium iodide, stopper the flask and allow to stand protected from light for 15 minutes. Add 2 mL of starch solution as indicator. Titrate the liberated iodine with 0.1m sodium thiosulfate VS. Carry out a blank test. The difference between the volumes used in the two titrations corresponds to the amount of iodine liberated by ferric ion. The difference between the titrations is not more than 13.4 mL (5%).
Assay
Weigh and powder 20 tablets. Dissolve a quantity of the powder containing 0.3 g of ferrous fumarate in 7.5 mL of 1m sulfuric acid with gentle heating. Cool, add 25 mL of water and titrate immediately with 0.1m ammonium cerium(iv) sulfate VS using ferroin solution as indicator. Each mL of 0.1m ammonium cerium(iv) sulfate VS is equivalent to 5.585 mg of Fe(ii).
Labelling
The quantity of the active ingredient is stated both as the amount of ferrous fumarate and in terms of the equivalent amount of ferrous iron.