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1. (WO2019048674) IRON COMPLEX COMPOUNDS FOR THERAPEUTIC USE
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CLAIMS

A process for preparing an iron complex compound comprising the steps of

(i) providing an iron preparation comprising iron in a form selected from a water- soluble iron salt, an iron hydroxide or an iron oxide-hydroxide, wherein

the amount of arsenic in the iron preparation does not exceed 4.5 μg per g of iron, and

the amount of lead in the iron preparation does not exceed 1 .5 μg per g of iron; and

(ii) contacting the iron preparation with a ligand in the presence of water so as to form the iron complex compound.

The process of claim 2, wherein

the amount of cadmium in the iron preparation does not exceed 0.6 μg per g of iron, and

the amount of mercury in the iron preparation does not exceed 0.9 μg per g of iron.

The process of claim 1 or claim 2, wherein

the amount of chromium in the iron preparation does not exceed 330 μg per g of iron.

4. The process of any one of claims 1 -3, wherein the amount of aluminum in the iron preparation does not exceed 200 μg per g of iron.

The process of any one of claims 1 -4, wherein the iron preparation is obtained

(a) from iron pentacarbonyl; or

(b) by recrystallization of an iron salt from an aqueous solution thereof, preferably by recrystallization of ferric nitrate from an aqueous solution containing nitric acid; or

(c) by extracting an aqueous iron salt solution with an organic solvent, preferably by extracting a ferric chloride solution with an alcohol having from 4 to 20 carbon atoms or an organic solution of an amine salt; or

(d) from iron precipitated at an anode during electrolysis of an aqueous iron salt solution, preferably an aqueous solution comprising iron chloride or iron sulfate; or

(e) by contacting an aqueous iron salt solution with a base so as to form a

precipitate of iron hydroxide and separating the precipitate from the liquid by filtration or centrifugation, wherein the base is preferably selected from sodium hydroxide and sodium carbonate; or

(f) by distillation of ferric chloride from a mixture comprising ferric chloride and nonvolatile impurities.

An iron complex compound, wherein

the amount of arsenic in the iron complex compound does not exceed 4.5 μg per g iron, and preferably does not exceed 1.5 μg per g of iron, and

the amount of lead in the iron complex compound does not exceed 1.5 μg per g iron, and preferably does not exceed 0.5 μg per g of iron.

The iron complex compound of claim 6, wherein

the amount of cadmium in the iron complex compound does not exceed 0.6 μg per g of iron, and preferably does not exceed 0.4 μg per g of iron, and the amount of mercury in the iron complex compound does not exceed 0.9 μg per g of iron, and preferably does not exceed 0.3 μg per g of iron.

The iron complex compound of claim 6 or claim 7, wherein

the amount of chromium in the iron complex compound does not exceed 330 μg per g of iron, and preferably does not exceed 100 μg per g of iron.

An iron complex compound, wherein the amount of aluminum in the iron complex compound does not exceed 200 μg per g iron, and preferably does not exceed 25 μg per g of iron.

The process of any one of claims 1 -5 or the iron complex compound of any one of claims 6-9, wherein the iron complex compound is an iron carbohydrate complex compound wherein, optionally, the content of reducing aldehyde groups in the carbohydrate that serves as ligand in the iron complex compound has been reduced by oxidation, hydrogenation, or a combination of both.

The process or the iron complex compound of claim 10, wherein the iron

carbohydrate complex compound is selected from iron carboxymaltose, iron polyglucose sorbitol carboxymethyl ether complex, iron mannitol complex, iron dextran, iron hydrogenated dextran, iron oxidized dextran, iron carboxyalkylated reduced oligo- and polysaccharides, iron sucrose, iron gluconate, iron dextrin, iron hydrogenated dextrin, iron oxidized dextrin, iron polymaltose, iron hydrogenated polymaltose, iron oligomaltose, hydrogenated iron oligomaltose, iron polyisomaltose, iron hydrogenated polyisomaltose, iron hydrogenated oligosaccharides such as iron hydrogenated oligoisomaltose, iron hydroxyethyl starch, iron sorbitol, iron dextran glucoheptonic acid and a mixture of two or more thereof.

The process of any one of claims 1 -5 or the iron complex compound of any one of claims 6-9, wherein the iron complex compound is a polymeric ligand-substituted oxo-hydroxy iron complex compound.

The process or the iron complex compound of claim 12, wherein the ligand is selected from a carboxylic acid, such as adipic acid, glutaric acid, tartaric acid, malic acid, succinic acid, aspartic acid, pimelic acid, citric acid, gluconic acid, lactic acid and benzoic acid; a food additive such as maltol, ethyl maltol and vanillin; an anion with ligand properties such as bicarbonate, sulphate and phosphate; a mineral ligand such as silicate, borate, molybdate and selenate; an amino acid such as tryptophan, glutamine, proline, valine and histidine; and a nutrient-based ligand such as folate, ascorbate, pyridoxine and niacin; and a mixture of two or more thereof.

The iron complex compound of any one of claims 6-13, for use in treatment or prophylaxis of iron-deficiency in a non-human animal, wherein the iron complex compound is optionally selected from iron dextran, iron hydrogenated dextran and iron dextran glucoheptonic acid.

The iron complex compound of any one of claims 6-13 for use in treatment or prophylaxis of iron-deficiency in a human subject, preferably a human subject suffering from lost or impaired kidney function, for example a human in need of dialysis.