Ferric Derisomaltose

FERRIC DERISOMALTOSE is an iron replacement product that helps bodies to fight iron deficiency or anemia. This compound is widely used for producing medicines related to growth and development. It uses an iron carbohydrate complex composed of ferric hydroxide and the carbohydrate derisomaltose. It is an iron carbohydrate oligosaccharide that releases iron suitable for the human body. The compound is in a non-ionic water-soluble form that quickly gets absorbed by human bodies. It also gets easily dissolved in water while preparing injection dosages as well. ( WBCIL’s patent needs to be pointed out)

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Molecular Formula – C18H34FeO16+3
Molecular Weight – 235 g/mole
Melting Point –
CAS No. – 1370654-58-2
Shelf Life – 36 months
Storage Advice – Store at room temperature in a dry place and keep the container protected from sunlight. Avoid opening the container if not used to avoid dust contamination.
Packing Size – 20 kg in sterile HDPE drum

HSN Code – 2821.1010

Sli No.	TEST PARAMETERS	SPECIFICATION	RESULTS
1.	Description	Brown coloured free flowing powder	Brown coloured free flowing powder
2.	Solubility	Highly soluble in water and dissolves in hot mineral acid	Highly soluble in water and dissolves in hot mineral acid
3.	Identification
	A. Positive for Iron	A. Positive for Iron	A. Positive for Iron
	B. Positive for Carbohydrate	B. Positive for Carbohydrate	B. Positive for Carbohydrate
	C. FTIR	C. sample spectrum matches with working STD spectrum	C. sample spectrum matches with working STD spectrum
4.	Molecular Weight	NMT 155000 Dalton	48052 Dalton
5.	pH (of 5% w/v aqueous solution)	5.5-8.0	7.61
6.	Loss on Drying (at 105 ⁰C for 4 hrs)	NMT 6.0% w/w	2.80% w/w
	Chloride (On Dried Basis)	NMT 3.0% w/w	1.48% w/w
8.	Arsenic	NMT 2.0 ppm	< 2.0 ppm
9.	Lead	NMT 10.0 ppm	< 10.0 ppm
10.	Copper	NMT 60.0 ppm	< 60.0 ppm
11.	Zinc	NMT 150.0 ppm	< 150.0 ppm
12.	Carbohydrates (On Dried Basis)	NLT 24.0 ⁰/0 w/w	28,39 ⁰/0 w/w
13.	Iron Content (On Dried Basis)	NLT 20.0% w/w	28,90 ⁰/0 w/w
14.	Total Microbial Count	NMT 100 cfu/gm	< 100 cfu/gm
15.	Total Combined Yeasts & Mould	NMT 10 cfu/gm	< 10 cfu/gm
16.	Endotoxin	NMT 0.35 EU/mg	< 0.35 ElJ/mg
	Osmolality	NMT 450 mosmol/kg	220 mosmol/kg
18.	OVI A) Methanol B) Acetone C) IPA	Limit as per ICH	Complies
19.	Free Ferric Iron	Absent	Absent
20.	Related Substance/ Impurities	Low molecular weight iron — carbohydrate complex	Not detected

Category	Description
Drug usage	This complex compound is used to develop medicines that can deal with iron deficiency or anemia and increase red blood cells in human bodies. The compound is also used for patients dealing with non-dialysis-dependent chronic kidney disease (CKD). The compound can replace other iron supplements. It is vastly used in the medical and pharmaceutical fields.
Food usage	Though it is proven to have benefits in dealing with iron deficiency, it is not used by the food industries to prepare any kind of food item.

Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial

Background: For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We...

An evaluation of ferric derisomaltose as a treatment for anemia

Introduction: Originally approved in Europe in 2009, ferric derisomaltose is the most recently authorized intravenous iron compound in the United States of America (2020). Ferric derisomaltose given as a rapid high-dose infusion can allow complete iron repletion in a single...