Iron Isomaltoside

Iron Isomaltoside, also known as Ferric Isomaltoside or MonoFer, is a dark reddish brown powder containing 24% iron (III) commonly used to treat patients with iron deficiency anemia. Its scientific molecular formula is C18H34FeO16, and its molecular weight is 235 g/mole. Iron Isomaltoside comprises iron and a carbohydrate moiety and is bonded in a matrix structure. It is unassociated with hypophosphatemia, has less insusceptible potential and less potential to let out labile iron. Because of its complex structure, iron Isomaltoside can usually be given in high doses, with a maximum single dose of 20 mg/kg body weight. Iron Isomaltoside can easily dissolve in water and is usually taken as tablets or as a sterile injection. It is very effective to treat IDA as an anti-anemic medication.

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Chemical name – Iron (III) hydroxide isomaltoside 1000.
Synonym – iron isomaltoside, iron isomaltooligosaccharide, iron oligosaccharide, iron isomaltopentaoside, ferric derisomaltose, or MonoFer.
Molecular Formula – C18H34FeO16
Molecular Weight – 235 g/mole
CAS No – 1370654-58-2
Shelf Life – 36 months
Storage Condition – Keep well closed, protected against light, dry, and at room temperature.
Packing Size – 20 kg in sterile HDPE drum
HSN Code – 2821.1010
Additional Info

  1. Economical & readily available
  2. Non – infringing process
  3. DMF ready & available

Features – Deep brown coloured free-flowing powder.
Solubility – Soluble in water.
Identification – Positive for Iron and Carbohydrates.
pH (of 5% w/v aqueous suspension) – 5.50 – 8.00
Loss on Drying (at 105°C for 4 hr) – NMT 8.00% w/w.
Arsenic – NMT 3.0ppm.
Heavy Metals (as Lead) – NMT 10.0ppm.
Chloride (On Dried Basis) – NMT 6.0%w/w.
Carbohydrates (Isomaltoside)(On Dried Basis) – NLT 25.0%w/w.
Assay For Elemental Iron (On Dried Basis) – NLT 25.0% w/w.
Total Microbial Count – NMT 100 cfu/g.
Total Combined Yeasts & Mould – NMT 10 cfu/g.
E. Coli – Absent/gm.
Salmonella – Absent/10gm.

Drug Uses: Iron Isomaltoside usually works as an active ingredient in human drugs to treat IDA or ID patients.
Ferric derisomaltose injection is an iron replacement used to treat people having iron deficiency anemia (not enough iron in the blood) who have non-dialysis-dependent chronic kidney disease (CKD).
It is also advised for patients who take iron supplements.

Medication Uses : Iron Isomaltoside works as Hematinics (Agents that improve the quality of the blood in the human body and increase the hemoglobin level and the number of erythrocytes.)
Iron Isomaltoside helps supply oxygen to blood cells.

Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage

Abstract Background and objectives: To explore if intravenous iron isomaltoside (Monofer®) leads to a better relief of fatigue than current treatment practice with oral iron in women suffering from severe fatigue after postpartum hemorrhage. Materials and methods: This is a...

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Iron Therapy in Chronic Kidney Disease: Days of Future Past

Abstract Anemia affects millions of patients with chronic kidney disease (CKD) and prompt iron supplementation can lead to reductions in the required dose of erythropoiesis-stimulating agents, thereby reducing medical costs. Oral and intravenous (IV) traditional iron preparations are considered far...

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Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy

Abstract Purpose: To evaluate the efficacy and safety for mother and child of using intravenous iron isomaltoside (IV-IIM) during pregnancy. Methods: Using an appointment register, we retrospectively identified all pregnant women who received a single dose of 1000 or 1500...

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Intravenous iron supplementation therapy

Abstract Intravenous infusions of iron have evolved from a poorly effective and dangerous intervention to a safe cornerstone in the treatment of iron deficiency. Modern iron formulations are composite nanoparticles composed of carbohydrate ferric oxy-hydroxides. Iron dextran, iron derisomaltose (formely...

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