| CAS No.: | 8047-67-4 , 8047-67-4 |
| Molecular Weight: | 180.16 g/mol |
| Chemical Formula | NA,C18H24Fe2O24 , C12H29Fe5Na2O23 |
Synonyms: Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Iron(III) hydroxide sucrose complex, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide.
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, though they have slighty different composition. 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.
The names and CAS number for Iron sucrose and Iron saccharate are interchangably used and often there is a confusion.
Iron sucrose and Iron saccharate are generally described as:
GHS Hazards Classification (According to EU Regulation 1272/2008 and US OSHA 1910.1200)
Not a hazardous substance by GHS.
EU Classification (According to EU Regulation 67/548/EEC)
Not a hazardous substance by this Classification.
Specifications of Iron Sucrose:
Appearance: Iron Sucrose is 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
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%.
Chlorides: 335 TO 720 PPM.
Assay of Sucrose By HPLC: Between 79% and 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.
Iron Sucrose Injection USP Grade:
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.
Packaging and storage: Preserve in single-dose containers of Type I glass. Store at controlled room temperature. Do not freeze.
Identification:
A: Iron: To 2.5 mL of Injection add 17.5 mL of water and 5 mL of hydrochloric acid, mix, and heat for 5 minutes in a boiling water bath. Cool, add drop-wise 13.5 N ammonium hydroxide until no further precipitation of ferric hydroxide occurs, and filter. Wash the precipitate with water to remove excess ammonium hydroxide, dissolve the precipitate in a minimum volume of 2 N hydrochloric acid, and add sufficient water to make a volume of 20 mL. To 3 mL of the solution so obtained add 1 mL of 2 N hydrochloric acid and 1 mL of potassium thiocyanate: the resulting solution (Solution 1) is red. To 1 mL of Solution 1 add 5 mL of amyl alcohol or ethyl ether, shake, and allow to stand: the organic layer is pink. To a separate 1-mL aliquot of Solution 1 add 2 mL of mercuric chloride: the red color is discharged [iron (III) salts].
B: Sucrose: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for sucrose.
C: Molecular weight determination: To pass the test
The molecular weight distribution curve obtained for the Injection conforms to the following parameters:
MW = 34,000–60,000 Da,
MN = not less than 24,000 Da, and
MW / MN = not more than 1.7.
Specific gravity: not less than 1.135 and not more than 1.165 at 20C.
Bacterial endotoxins: not more than 3.7 USP Endotoxin Units per mg of iron contained in the Injection.
Alkalinity: Transfer 5 mL of Injection to a suitable vessel, and titrate with 0.1 N hydrochloric acid with constant stirring to a pH of 7.4. Record the volume of 0.1 N hydrochloric acid consumed, and calculate the alkalinity of the Injection as the volume of acid, in mL, consumed per mL of Injection. Not less than 0.5 mL and not more than 0.8 mL of 0.1 N hydrochloric acid is consumed per mL of Injection.
pH: between 10.5 and 11.1 at 20 .
Osmolarity: not less than 1150 mOsmol per L and not more than 1350 mOsmol per L for the Injection. The solution for test is prepared by diluting the Injection 1 in 10.
Absence of low-molecular weight Fe(II) and Fe(III) complexes: To pass the test.
Particulate matter: To meet the requirement.
Limit of iron (II): Not more than 0.4% (w/v) of iron (II) is found.
Content of chloride: The chloride content of the Injection is not less than 0.012% and not more than 0.025%.
Assay for sucrose: To meet the requirement.
Assay for iron: To meet the requirement.
Iron Sucrose Injection BP Ph Eur Grade:
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.
IDENTIFICATION
A. To a quantity of the injection containing the equivalent of 20 mg of iron, add 20 mL of water and 5 mL of hydrochloric acid and boil for 5 minutes. Cool, add an excess of 13.5M ammonia and filter. Wash the precipitate with water, dissolve in the minimum volume of 2M hydrochloric acid and add sufficient water to produce 20 mL The resulting solution yields reaction B characteristic of iron salts.
B In the Assay for Sucrose, the retention time of the principal peak in the chromatogram obtained with solution (1) corresponds to that of the principal peak in the chromatogram obtained with solution (2).
C. Complies with the test for Molecular weight determination.
TESTS
Alkalinity: pH, 10.5 to 11.0.
Osmolality: The osmolality, of the injection is 1150 mosmol/kg to 1350 mosmol/kg.
Clarity of solution: To a quantity of the injection containing 10 mg of iron, add 100 mL of water and adjust to pH 6.0 with 0.1M hydrochloric acid. The solution must not have any turbidity. Add 0.1M hydrochloric acid drop-wise until a faint turbidity develops, the pH of the solution is between 4.4 and 5.3.
Molecular weight determination: To pass the test.
the weight-average molecular weight MW = 34,000 to 60,000
and the number-average molecular weight MN = Not less than 24,000 Da
MW/MN = Not more than 1.7.
