Crystal Clear Products Ankleshwar India
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

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Ferric Saccharate Iron D Saccharate Iron Sucrose Commercial Pure & BP Ph Eur USP Supplements Grade Manufacturers & Exporters

Please check Specifications of Ferric Saccharate Iron D Saccharate Iron Sucrose USP NF ACS BP Ph Eur EP JP IP Analytical reagent FCC Food grade Manufacturers our associates world class FDA-GMP approved, ISO-9001 Certified facility Anmol Chemicals

Ferric Saccharate Iron D Saccharate Iron Sucrose Suppliers Manufacturers
Ferric Saccharate Iron D Saccharate Iron Sucrose CAS Number 8047-67-4

Iron saccharate (Sucroferric oxyhydroxide or Iron Sucrose) is used as a source of iron in patients with iron deficiency anemia with chronic kidney disease. It is often refered to as Iron Sucrose. Ferric Saccharate and Iron Sucrose are often used interchangably. Iron Sucrose is a more common commercial product.

Iron sucrose has chemical formula of C12H29Fe5Na2O23. The iron sucrose molecule is a polymer with two main molecules; sucrose (chemical formula C12H22O11) and an iron (III) hydroxide (Na2Fe5O8•3(H2O)). These two components are in solution together, but are not bound to one anotherIron is a mineral that the body needs to produce red blood cells. Iron sucrose injection is an iron replacement product that is used to treat iron deficiency anemia. Formulators make Iron sucrose Supplements. Intravenous iron sucrose is a commonly used treatment for iron deficiency anemia. Iron sucrose replaces iron in the blood to foster red blood cell production in patients with chronic kidney disease. The chemical formula of iron sucrose is C12H29Fe5Na2O23.

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.

PRODUCTION
Iron Sucrose Injection is produced by a method of manufacture designed to provide an iron-sucrose complex with appropriate iron absorption characteristics. This may be confirmed for routine control purposes by the use of an appropriate combination of physico-chemical tests, subject to the agreement of the competent authority.
A suitable test is carried out to demonstrate (1) the amount of iron(II) present in the injection is not more than 0.4% w/v of the total iron content and (2) there are no low molecular weight complexes in the injection.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of iron, Fe: 95.0 to 105.0% of the stated amount.
Content of sucrose: 90.0 to 110.0% of the stated amount.

Complies with specification of BP Ph monograph.

SDS MSDS of Ferric Saccharate Iron D Saccharate Iron Sucrose BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers

Crystal Clear Products and the group companies are manufacturing chemicals since several decades. We have automatic vacuum operated titanium evaporators and SS316 equipments to produce top grade of chemical products. We have toll manufacturers and representatives in China, UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Bangkok Thailand, Kaula Lumpur Malaysia, Dubai UAE etc. & sales representative in Chicago, Houston New York & Los Angeles, USA. Associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified, Crisil Rated.

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Crystal Clear Products
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

e-mail: info@crystalclearproducts.org

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