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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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WBCIL is one of the leading suppliers of Ferric DerIsomaltose in India that offers high-quality compounds that can meet all the industry criteria. The company offers the best ferric derisomaltose cost for pharmaceutical uses.

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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...

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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...

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