MonoFer Description

ACTIVE INGREDIENT: Ferric Derisomaltose 417 mg/ml eqv Elementary Iron 100 mg/ml.
Ferric derisomaltose is a dark reddish brown powder containing 24% iron (III). Ferric derisomaltose solution for injection is a colloid with iron in spheroidal iron-carbohydrate particles. The structure of the ferric derisomaltose particle has been characterised by carbon 13 NMR spectroscopic analysis which reveals that the complex forms a stable matrix type structure with about 10 iron(III) atoms to one molecule of isomaltoside pentamer with the iron(III) bound in cavities of the 3-D structure of isomaltoside pentamers, leading to a low content of free iron based on in vitro data.
Chemical name: Iron (III) hydroxide isomaltoside 1000.
Synonyms: iron isomaltoside, iron isomaltooligosaccharide, iron oligosaccharide, iron isomaltopentaoside.
Molecular Formula: {FeO(1-3X)(OH)(1+3X)(C₆H₅O₇₃-)X}, (H₂₀)T, -(C₆H₁₀O₆)R(-C₆H₁₀O₅-)Z(C₆H₁₃O₅)R, (NaCl)Y X= 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14.
This unit has a molecular weight of 235 g/mole - The molecular weight of the colloid particle is approximately 165 kDa hence the colloid particle contains approximately 700 repeatable units (165,000/235).
CAS number: 1345510-43-1.
Monofer is a sterile, dark brown, non-transparent solution with pH 5.0-7.0 containing ferric derisomaltose dissolved in water for injection. The pH may have been adjusted with hydrochloric acid or sodium hydroxide, and the product is filled under nitrogen gas.
Excipients/Inactive Ingredients: Water for injections, Sodium hydroxide, Hydrochloric acid.