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. |
*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 |
*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: | Not more than 100 cfu/mL Should be absent |
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 powder |
Solubility | Freely soluble in water |
Identification Iron (ferric ion) Sucrose(by HPLC) | It responds to test for ferric ion. |
*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 |
*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 |
*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: | Not more than 500 cfu/mL Should be absent per g |
© Pride 2020 | All Rights Reserved. Powered by Alhev