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Iron, Manganese & Zinc Gluconate

Iron Ferrous Gluconate, Manganese Gluconate, Zinc Gluconate USP BP Ph Eur FCC food Grade Supplier, Manufacturer's Representative, CAS Number 12389-15-0 for dihydrate & 299-29-6 for anhydrous C12H22FeO14, and 6485-39-8 MnC12H22O14, and 4468-02-4 C12H22O14Zn

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DESCRIPTION

Ferrous Gluconate USP Grade
Formula: C12H22FeO142H2O
Weight: 482.17
D-Gluconic acid, iron(2+) salt (2:1), dihydrate.
Iron (2+) gluconate (1:2) dihydrate CAS Number 12389-15-0.
Anhydrous 446.15 CAS Number 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 FCC Food Grade
Iron (II) Gluconate
Formula: C12H22FeO14·2H2O
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 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-gluconat
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.

Manganese Gluconate USP Grade
C12H22MnO14 (anhydrous) --- 445.23
Bis(D-gluconato-O1,O2) manganese.
Manganese D-gluconate (1:2).
Dihydrate --- 481.27

Manganese Gluconate is dried or contains two molecules of water of hydration. It contains not less than 98.0 percent and not more than 102.0 percent of C12H22MnO14, calculated on the anhydrous basis.

Identification:
A: A solution (1 in 20) responds to the tests for Manganese.
B: Chromatographic plate test.
Water: Where labeled as the dried form: between 3.0% and 9.0%, the determination being performed by stirring the mixture containing the Test preparation, maintained at a temperature of 50 , for 30 minutes before titrating with the Reagent. Where labeled as the dihydrate: it is between 6.0% and 9.0%.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 0.70 mL of 0.020 N hydrochloric acid (0.05%).
Sulfate: A 2.0-g portion shows no more sulfate than corresponds to 4.0 mL of 0.020 N sulfuric acid (0.2%).
Limit of lead: To pass the test (0.001%).
Heavy metals: the limit is 20 @g per g.
Reducing substances: the limit is 1.0%.

Manganese Gluconate FCC Food Grade
C12H22MnO14·2H2O Formula wt, dihydrate 481.27
C12H22MnO14 Formula wt, anhydrous 445.24
CAS: 6485-39-8

DESCRIPTION
Manganese Gluconate occurs as a slightly pink powder. The anhydrous form is obtained by spray-drying, and the dihydrate is obtained by crystallization. It is very soluble in hot water and is very slightly soluble in alcohol.
Function: Nutrient.

REQUIREMENTS
Identification:
A. A 1:20 aqueous solution gives positive tests for Manganese.
B: Chromatographic plate test.
Assay: Not less than 98.0% and not more than 102.0% of C12H22MnO14, calculated on the anhydrous basis.
Arsenic: Not more than 3 mg/kg.
Lead: Not more than 2 mg/kg.
Reducing Substances: Not more than 1.0%.
Water: Anhydrous: Between 3.0% and 9.0%; Dihydrate: Between 6.0% and 9.0%.

Zinc Gluconate USP Grade
Formula: C12H22O14Zn
Weight: 455.68
Bis(D-gluconato-O1,O2) zinc.
Zinc D-gluconate (1:2) CAS 4468-02-4.

Zinc Gluconate contains not less than 97.0 percent and not more than 102.0 percent of C12H22O14Zn, calculated on the anhydrous basis.

Identification:
A: A solution (1 in 10) responds to the tests for Zinc.
B: Chromatographic plate test.
pH: between 5.5 and 7.5, in a solution (1 in 100).
Water: not more than 11.6%.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 0.70 mL of 0.020 N hydrochloric acid (0.05%).
Sulfate: A 2.0-g portion shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (0.05%).
Arsenic: the limit is 3 ppm.
Reducing substances: the limit is 1.0%.
Limit of cadmium: the limit is 5 ppm.
Limit of lead: To pass the test (0.001%).

Zinc Gluconate FCC Food Grade
Formula: C12H22O14Zn
Weight: 455.68
CAS: 4468-02-4

DESCRIPTION
Zinc Gluconate occurs as a white or nearly white, granular or crystalline powder and as a mixture of various states of hydration, up to the trihydrate, depending on the method of isolation. It is freely soluble in water and very slightly soluble in alcohol.
Function: Nutrient

REQUIREMENTS
Identification:
A: A 1:10 aqueous solution gives positive tests for Zinc.
B: Chromatographic plate test.
Assay: Not less than 97.0% and not more than 102.0% of C12H22O14Zn, calculated on the anhydrous basis.
Cadmium: Not more than 2 mg/kg.
Chloride: Not more than 0.05%.
Lead: Not more than 2 mg/kg.
Reducing Substances: Not more than 1.0%.
Sulfate: Not more than 0.05%.
Water: Not more than 11.6%.


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