Ferric Derisomaltose

1345510-43-1

1. DESCRIPTION - BROWN OR DARK BROWN FREE FLOWING POWDER

2. SOLUBILITY - SOLUBLE IN WATER AND HOT MINERAL ACID

3. IDENTIFICATION - POSITIVE FOR IRON & CARBOHYDRATE

4. PH (OF 5% W/V AQUEOUS SOLUTION) - 5.5 – 8.0

5. WATER CONTENT( BY KF) - NMT 6.0% W/W

6. ARSENIC - NMT 2.0 PPM

7. HEAVY METALS (AS LEAD) - NMT 20.0 PPM

8. COPPER - NMT 60.0 PPM

9. ZINC - NMT 150.0 PPM

10. FREE FERRIC IRON - NMT 0.1%

11. CHLORIDE (ON ANHYDROUS BASIS) - NMT 3.0% W/W

12. CARBOHYDRATES (ON ANHYDROUS BASIS) - NLT 30.0% W/W

13. IRON CONTENT (ON ANHYDROUS BASIS) - NLT 20.0% W/W

14. RESIDUAL SOLVENTS - METHANOL : NMT 3000 PPM; ACETONE : NMT 5000 PPM

15. OSMOLARITY - LESS THAN 800 mOsm/L

16. MOLECULAR WEIGHT - 1,00,000 TO 2,00,000 DALTON; POLYDISPERSITY NMT 2.0

17. BACTERIAL ENDOTOXINS - NMT 0.5 EU/MG OF IRON

18. FILTERABILITY - 10 ML SOLUTION CONTAINING 110 MG/ML OF IRON PASSES THROUGH 1.0µ, 0.45µ FILTER

Experienced Technicians; International Approvals/Standards; Price; Product Features; Product Performance; Prompt Delivery; Quality Service; Small Orders Accepted; GTZ India Pvt Ltd, a GMP approved leading R&D and API manufacturer based out of Kolkata, West Bengal, India offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded product.

Our primary offerings includes Ferric Carboxymaltose, Ferric Derisomaltose, Iron Isomaltoside, Ferric Maltol, Ferric Citrate, L-Methylfolate USP, Methyl Tetrahydrofolate, Calcium Citrate Malate, Chelated Minerals & organic molecules.

DC Grade & Customized Products are the pillars on which GTZ has built its reputation in the market.

India

gram; kilogram; Ton