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Iron Sucrose and Ferric Saccharate or Iron D Saccharate or Sucroferric Oxyhydroxide USP Grade Supplier Exporter Manufacturers' Representative |
Email: info@ammol.org |
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Iron Sucrose and Ferric Saccharate or Iron D Saccharate or Sucroferric Oxyhydroxide
CAS Number: 8047-67-4
Molecular Formula: Varies
Molecular Weight: Varies
Iron Sucrose and Ferric Saccharate or Iron D Saccharate or Sucroferric Oxyhydroxide
General Specifications of Iron Sucrose:
Appearance: Reddish deep brown colored amorphous Powder, with characteristic odor and hygroscopic in nature.
Solubility: 10 % w/v Easily soluble in water.
Molecular Weight Determination (By GPC):
(a) The Weight Average Mol. Wt. (Mw): 34,000 - 60,000Da
(b) The No. Average Mol. Wt. (Mn): 24,000 Da.
(c) Index (Mw/Mn): Maximum 1.7
Loss On Drying: 5% maximum at 105C.
Tapped Bulk Density: Between 0.65 and 1.2 w/v.
Specific Gravity at 20C for ( 2%w/v Iron Solution): 1.135 TO 1.165
Bacterial Endotoxin Test: 3.7 EU/mg of Iron maximum.
Alkalinity ( 2%w/v Iron Solution): Minimum 0.5 and Minimum 0.8 mI of 0.1 N HCl
pH (2%w/v Iron Solution): 9.5 to 11.1
Chloride: Between 335 ppm and 720 ppm.
Water: 5% maximum.
Osmolarity ( 2%w/v Iron Solution): Minimum 1150 mOsmollLit. Minimum NMT 1350 mOsmollLit.
Absence of low Mol. Wt. Fe(II) & Fe(III) (2% w/v Iron solution): No additional peaks are found in polarogram in the test for limit of Fe (II).
Turbidity (2 %w/v Iron Solution): Turbidity should develop between pH 4.4 - 5.3
Limit of Iron(II): Maximum 1%.
Assay of Sucrose By HPLC (2% w/v Iron solution): 79% to 91%.
Assay of Iron on dry basis: Minimum 4.8 % w/w and Maximum 6.4 % w/w.
Total Bacterial count: Maximum 500 CFU/g
Total Yeast mould: Maximum 100 CFU/g
Bacterial Endotoxin: Maximum 100 CFU/g
Total Fungal count: Maximum 50 CFU/g
E. Coli: Absent.
Salmonella: Absent.
Staphylococcus aureus: Absent.
Pseudomonas aeruginosa: Absent.
Residual Solvent: Maximum 3000 ppm.
Cadmium: Maximum 5 ppm.
Lead: Maximum 5 ppm.
Arsenic: Maximum 3 ppm.
Specifications of Iron Sucrose Injection USP Grade Specifications:
Iron Sucrose Injection is a sterile, colloidal solution of ferric hydroxide in complex with Sucrose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of iron. Sodium Hydroxide may be added to adjust the pH. It contains no antimicrobial agent, chelating agent, dextran, gluconate, or other added substances.
Complies with specifications of USP Monograph.
Specifications of Iron Sucrose Injection BP Ph Eur Grade Specifications:
Action and use: Treatment of iron-deficiency anaemia.
DEFINITION
Iron Sucrose Injection is a sterile colloidal solution containing a complex of iron(III) hydroxide with sucrose of average molecular weight between 34000 and 60000.
Complies with specification of BP Ph monograph.
Please visit SDS Safety Data Sheet of Iron Sucrose and Ferric Saccharate or Iron D Saccharate or Sucroferric Oxyhydroxide Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org