Iron (II) Gluconate or Ferrous Gluconate Specifications of Commercial Pure & BP Ph Eur USP IP FCC Food Grade Manufacturers & Exporters
Please visit Iron (II) Gluconate or Ferrous Gluconate 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
Iron (II) Gluconate or Ferrous Gluconate CAS Number 299-29-6 & 12389-15-0
Ferrous Gluconate USP Grade Specifications:
C12H22FeO14-2H2O --- 482.17
d-Gluconic acid, iron(2+) salt (2:1), dihydrate;
Iron(2+) gluconate (1:2) dihydrate CAS 12389-15-0.
Anhydrous 446.15 CAS 299-29-6
DEFINITION
Ferrous Gluconate contains NLT 97.0% and NMT 102.0% of ferrous gluconate (C12H22FeO14), calculated on the dried basis.
IDENTIFICATION
A. Thin-Layer Chromatography
B. Ferrous Ion
Sample solution: 5 mg/mL in water
Analysis: Add potassium ferricyanide to the Sample solution.
Acceptance criteria: The solution yields a dark blue precipitate.
Chloride and Sulfate, Chloride: To pass the test. --- 0.07%
Chloride and Sulfate, Sulfate: To pass the test. --- 0.1%
Mercury: NMT 3 ppm
Arsenic: To pass the test. --- NMT 3 ppm
Limit of Lead: To pass the test. --- (NMT 10 ppm).
Limit of Ferric Iron: To pass the test. --- NMT 2.0%
Oxalic Acid: To pass the test.
Reducing Sugars: To pass the test.
Loss on Drying:
Analysis: Dry at 105C for 16 h.
Acceptance criteria: 6.5% to 10.0%
Specifications of Ferrous Gluconate BP Grade Ph Eur
Ferrous Gluconate
DEFINITION
Iron (II) di(D-gluconate).
Content: 11.8 per cent to 12.5 per cent of iron(II) (dried substance). It contains a variable amount of water.
CHARACTERS
Appearance: Greenish-yellow or grey powder or granules.
Solubility: Freely but slowly soluble in water giving a greenish-brown solution, more readily soluble in hot water, practically insoluble in ethanol (96 per cent).
IDENTIFICATION
A. Thin-layer chromatography.
B. 1 ml of solution S (see Tests) gives reaction of iron.
TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water prepared from distilled water and heated to about 60C, allow to cool and dilute to 50 ml with carbon dioxide-free water prepared from distilled water.
Appearance of solution: The solution is clear.
pH: 4.0 to 5.5 for solution S, measured 3-4 h after preparation.
Sucrose and reducing sugars: To pass the test.
Chlorides: Maximum 0.06 per cent.
Oxalates: To pass the test.
Sulphates: Maximum 500 ppm.
Arsenic: Maximum 2 ppm, determined on 0.5 g.
Barium: To pass the test.
Ferric ion: Maximum 1.0 per cent.
Heavy metals: Maximum 20 ppm.
Loss on drying: 5.0 per cent to 10.5 per cent, determined on 0.500 g by drying in an oven at 105C for 5 h.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate count.
Ferrous Gluconate IP
Ferrous Gluconate IP grade is also offered.
Ferrous Gluconate FCC Food Grade
Iron (II) Gluconate
C12H22FeO14-2H2O --- Formula weight 482.18
INS: 579 ---CAS 299-29-6
DESCRIPTION
Ferrous Gluconate occurs as a fine, yellow-gray or pale green-yellow powder or granules. One gram dissolves in about 10 mL of water with slight heating. It is practically insoluble in
alcohol. A 1:20 aqueous solution is acid to litmus.
Function: Nutrient; color adjunct.
REQUIREMENTS
Identification:
A. Dissolve a quantity of sample in water, heating in a water bath at 60C if necessary, to obtain a Test Solution containing 10 mg/mL. Similarly, prepare a Standard Solution of USP Ferrous Gluconate Reference Standard in water, diluting to 10 mg/mL. Apply separate 5- L portions of the Test Solution and the Standard Solution on a suitable thin-layer chromatographic
plate coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50:30:10:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110C for 20
minutes Allow to cool, and spray with a spray reagent prepared as follows: Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. After spraying, heat the plate at 110C for about 10 minutes The principal spot obtained from the Test Solution corresponds in color, size, and Rf value to that obtained from the Standard Solution.
B. A 1:20 aqueous solution gives positive tests for Ferrous Salts (Iron).
Assay: Not less than 97.0% and not more than 102.0% of C12H22FeO14, calculated on the dried basis.
Chloride: Not more than 0.07%.
Ferric Iron: Not more than 2.0%.
Lead: Not more than 2 mg/kg.
Loss on Drying: Between 6.5% and 10.0%.
Mercury: Not more than 3 mg/kg.
Oxalic Acid: To pass the test.
Reducing Sugars: To pass the test.
Sulfate: Not more than 0.1%. SDS MSDS of Iron (II) Gluconate or Ferrous Gluconate BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
