Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Treatment of iron-deficiency anaemia.
DEFINITION
Ferrous Sulfate Prolonged-release Tablets contain Dried Ferrous Sulfate. They are formulated so that the medicament is released over a period of several hours. They are coated.
PRODUCTION
A suitable dissolution test is carried out to demonstrate the appropriate release of ferrous sulfate. The dissolution profile should reflect the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of ferrous iron, Fe(II)
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. The powdered tablets yield reaction A characteristic of iron salts, Appendix VI.
B. Extract a quantity of the powdered tablets containing 0.15 g of Dried Ferrous Sulfate with 10 mL of 2M hydrochloric acid and filter. The filtrate yields reaction A characteristic of sulfates, Appendix VI.
ASSAY
Weigh and powder 20 tablets. Dissolve a quantity of the powder containing 0.5 g of Dried Ferrous Sulfate as completely as possible in a mixture of 30 mL of water and 20 mL of 1M sulfuric acid and titrate 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 active ingredient is stated both as the amount of dried ferrous sulfate and in terms of the equivalent amount of ferrous iron.
