Iron Sucrose INH

Iron Sucrose INH

  • Product Name : Iron Sucrose INH

Global Calcium is one of the leading manufacturers and exporters of Iron Sucrose INH CAS no. , API, (Active Pharmaceutical Ingredient). We support the customers with exhaustive documentation. As a USDMF & EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979.

As manufacturer of Iron Sucrose INH we hereby state the following facts about the drug:

Product NameCalcium Dobesilate Monohydrate EP
Product FormulaNa2Fe5O8 (OH)?3(H2O)] n?m(C12H22O11)
Molecular Weight340000-60000 Da
CAS Number8047-67-4
No.
Tests
Specifications
Reference
1Description
Reddish brown to dark brown powder
2Solubility (10% w/v)Freely soluble in water
3Identification
A. Iron
B. Sucrose
A. Red color is discharged (Iron [III] salts)
B. The retention time of the major peak obtained in the chromatogram of the Assay preparation corresponds to that obtained in the chromatogram of
the standard preparation as in the Assay for sucrose.
4Molecular weight determination
A. Weight average molecular weight, (Mw)
B. Number-average molecular weight, (Mn)
C. Polydispersity Index (Mw/Mn)
A. 34,000 and 60,000 Da
B. Not less than 24,000 Da
C. Not more than 1.7
5Assay of Iron (BY TITRIMETRY)
Between 4.8% and 6.0% w/w
6Loss on drying (w/w)
(At 105?C, 1Hr, Under IRMB))
Not more than 5.0%
7pH (2% w/v iron solution)
10.5 to 11.1
-
8Specific gravity at 20oC
(2.0% w/v Iron solution)
Between 1.135 - 1.165
9.
9Turbidity (2% w/v iron solution)
Turbidity should develop between pH 4.4-5.3Turbidity should develop between pH 4.4-5.3
10Alkalinity (2% w/v iron solution)
Between 0.5-0.8 mL of 0.1N hydrochloric acid
consumed / mL

11Chloride content
(2.0% w/v iron solution)
( As solid substance)
Between 0.012% - 0.025%
Between 0.03% - 0.08%

12Osmolarity (2% w/v iron solution)
Between 1150 mOsmol / L -1350 mOsmol / L

13Absence of low molecular weight Fe (II) and Fe (III) complexes ?(2% w/v iron solution)
No additional peaks area found in the test for limit of Fe (II)

14Limit of Fe (II) (2% w/v iron solution)
Not more than 0.4%

15Assay of Sucrose (BY HPLC)
a. 2% w/v iron solution
b. As solid
a. Between 260.0 mg - 340.0 mg / mL
b. Between 79.0% - 91.0%

16Residual solvents (BY GC)
Methanol : Not more than 3000 ppm

17Microbial limit test
i. Total aerobic microbial count
ii. Total Yeast and Mould count
Pathogens
a. Enterobacteriaceae
b. E. coli
c. Salmonella
d. Staphylococcus aureus
e. Pseudomonas aeruginosa
i. Not more than 100 cfu / g
ii. Not more than 10 cfu / g
a. To be absent in 1 g
b. To be absent in 10 g
c. To be absent in 10 g
d. To be absent in 10 g
e. To be absent in 10 g

18Bacterial Endotoxin test
Not more than 3.7 EU / mg of Iron

Global Calcium is a leading manufacturer of this drug. We manufacture this pharmaceutical drug and make it available to domestic and overseas market