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)
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.
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 |
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Drug usage |
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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. |