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Ferrous Gluconate
BP USP IP FCC Food Grade
Ferrous gluconate

Ferrous Gluconate: CAS Number: 299-29-6, Molecular Formula: C12H22FeO14, Molecular Weight: 446.14

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.

REQUIREMENTS
Identification:
A. Dissolve a quantity of sample in water, heating in a water bath at 60° 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 110° 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 110° 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%.


Ferrous Gluconate BP Grade Ph Eur

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 60 °C, 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 105 °C for 5 h.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate count.


Ferrous Gluconate USP Grade
C12H22FeO142H2O 482.17
D-Gluconic acid, iron(2+) salt (2:1), dihydrate.
Iron (2+) gluconate (1:2) dihydrate [12389-15-0].
Anhydrous 446.15 [299-29-6].

Ferrous Gluconate contains not less than 97.0 percent and not more than 102.0 percent of C12H22FeO14, calculated on the dried basis.

Identification:
A: It responds to Identification test B under Calcium Gluconate.
B: A solution (1 in 200) yields a dark blue precipitate with potassium ferricyanide TS.
Loss on drying: Dry it at 105 for 16 hours: it loses between 6.5% and 10.0% of its weight.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 1.0 mL of 0.020 N hydrochloric acid (0.07%).
Oxalic acid: Dissolve 1.0 g in 10 mL of water, add 2 mL of hydrochloric acid, and transfer to a separator. Extract successively with 50 mL and 20 mL of ether. Combine the ether extracts, add 10 mL of water, and evaporate the ether on a steam bath. Add 1 drop of 6 N acetic acid and 1 mL of calcium acetate solution (1 in 20): no turbidity is produced within 5 minutes.
Sulfate: A 1.0-g portion shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (0.1%).
Arsenic: he limit is 3 ppm.
Limit of ferric iron: Ferrous Gluconate contains not more than 2.0% of ferric iron.
Limit of lead: to pass the test by atomic absorption spectrophotometer. (0.001%).
Mercury: 3 ppm.
Reducing sugars: to pass the test.


Ferrous Gluconate IP


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