Ferrous Sulfate is an iron-containing pharmaceutical ingredient used as a source of elemental iron for the prevention and treatment of iron deficiency and iron deficiency anemia. It is an inorganic ferrous iron salt and is widely used in oral iron pharmaceutical formulations.
Ferrous Sulfate is available in different hydration states. Ferrous Sulfate Heptahydrate is commonly represented by CAS Number 7782-63-0, while anhydrous Ferrous Sulfate is represented by CAS Number 7720-78-7. Therefore, the CAS number and molecular weight should match the specific form being supplied.
Ferrous Sulfate provides ferrous iron (Fe²⁺), which is required for hemoglobin synthesis and normal red blood cell production. Following oral administration, iron is absorbed primarily in the small intestine and is subsequently utilized for hemoglobin formation and replenishment of iron stores.
Ferrous Sulfate is commonly supplied as tablets, capsules, oral solutions and other iron-containing pharmaceutical preparations.
Ferrous Sulfate supplies iron needed for the synthesis of hemoglobin, myoglobin and various iron-containing enzymes. Replenishment of iron supports normal erythropoiesis and helps correct iron deficiency.
Ferrous Sulfate is used as an iron source in pharmaceutical products for:
The specific indication and dosage should follow the approved product labeling and applicable regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |