Iron Sucrose

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Iron Sucrose Liquid

Iron sucrose is used in injectable formulations and is administered intravenously in the treatment
of iron deficiency anaemia. It is frequently used in patients undergoing haemodialysis, erythropoietin therapy, and/or in patients who have chronic kidney disease. At the same time
when Haemoglobin levels are extremely low in the patients and having limitations in administering oral iron supplements, our injectable product can be conveniently administered to
the patient.

Specifications:

Tests	Specifications
Description	Brown to dark brown coloured solution
Identification Iron (ferric ion) Sucrose(by HPLC)	It responds to test for ferric ion. 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.
*Specific gravity at 20°C (2.0 % W/V of Iron solution)	Not less than 1.135 and not more than 1.165.
Alkalinity (2.0%W/V of Iron solution)	Not less than 0.5 mL and not more than 0.8 mL of 0.1 N hydrochloric acid is consumed per ml
*pH at 20°C (2.0 % W/V of Iron solution)	Between 10.0 and 11.1
Osmolarity(2.0 %W/V of Iron solution)	Between 1150 mOsmol / L and 1350 mOsmol / L
*Absence of low molecular weight Fe (II) and Fe (III) complexes by Polarography (2.0 %W/V of Iron solution)	No additional peak should be found other than Fe (II) and Fe (III) complexes.
*Turbidity(2.0 % W/V of Iron solution )	Turbidity should develop between pH 4.4 and 5.3.
Limit test for iron (II) (2.0 %W/V of Iron solution)	Not more than 0.4%w/v
Content of Chloride (2.0 % W/V of Iron solution)	Not less than 0.012% W/W and not more than 0.025% W/W.
*Assay for Iron (by UV)	Not less than 3.0 % w/w
*Molecular weight determination (a) Weight average molecular weight (M W ) by GPC (b) Number average molecular weight (Mn) by GPC (c) Polydispersity index Mw/Mn	Between 34,000 to 60,000 Da Not less than 24,000 Da Not more than 1.7
*Assay for sucrose by HPLC (2.0 % W/V of Iron solution)	Not less than 260 mg and not more than 340 mg of sucrose per ml
*Bacterial endotoxin test	Not more than 3.7 EU/mg of iron
Microbiological examination: (a) Microbial Enumeration Tests: i) Total aerobic microbial count ii) Total combined yeasts and molds count (b)Test for Specified Microorganisms: i) Bile Tolerant Gram Negative Bacteria ii) Escherichia Coli iii) Salmonella spp iv) Pseudomonas aeruginosa v) Staphylococcus aureus vi) Clostridium sporogenes vii) Candida albicans	Not more than 100 cfu/mL Not more than 10 cfu/mL Should be absent Should be absent Should be absent Should be absent Should be absent Should be absent Should be absent

Iron Sucrose Powder

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Specifications:

Tests	Specifications
Description	Brown to dark brown coloured powder
Solubility	Freely soluble in water
Identification Iron (ferric ion) Sucrose(by HPLC)	It responds to test for ferric ion. 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.
*Specific gravity at 20°C (2.0 % W/V of Iron solution)	Not less than 1.135 and not more than 1.165.
Alkalinity (2.0%W/V of Iron solution)	Not less than 0.5 mL and not more than 0.8 mL of 0.1 N hydrochloric acid is consumed per ml
*pH at 20°C (2.0 % W/V of Iron solution)	Between 10.5 and 11.1
Osmolarity(2.0 %W/V of Iron solution)	Between 1150 mOsmol / L and 1350 mOsmol / L
*Absence of low molecular weight Fe (II) and Fe (III) complexes by Polarography (2.0 %W/V of Iron solution)	No additional peak should be found other than Fe (II) and Fe (III) complexes.
*Turbidity(2.0 % W/V of Iron solution )	Turbidity should develop between pH 4.4 and 5.3.
Limit test for iron (II) (2.0 %W/V of Iron solution)	Not more than 0.4%w/v
Content of Chloride (2.0 % W/V of Iron solution)	Not less than 0.012% W/W and not more than 0.025% W/W.
*Assay for Iron (by UV)	Not less than 3.0 % w/w
*Molecular weight determination (a) Weight average molecular weight (M W ) by GPC (b) Number average molecular weight (Mn) by GPC (c) Polydispersity index Mw/Mn	Between 34,000 to 60,000 Da Not less than 24,000 Da Not more than 1.7
*Assay for sucrose by HPLC (2.0 % W/V of Iron solution)	Not less than 260 mg and not more than 340 mg of sucrose per ml
Residual Solvents (a) Acetone (b) Methanol	Not more than 5000 ppm Not more than 3000 ppm
*Bacterial endotoxin test	Not more than 3.7 EU/mg of iron
Microbiological examination: (a) Microbial Enumeration Tests: i) Total aerobic microbial count ii) Total combined yeasts and molds count (b)Test for Specified Microorganisms: i) Bile Tolerant Gram Negative Bacteria ii) Escherichia Coli iii) Salmonella spp iv) Pseudomonas aeruginosa v) Staphylococcus aureus vi) Clostridium sporogenes vii) Candida albicans	Not more than 500 cfu/mL Not more than 50 cfu/mL Should be absent per g Should be absent per g Should be absent per 10 g Should be absent per g Should be absent per g Should be absent per g Should be absent per g