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Magnesium Gluconate BP USP FCC Food Grade Manufacturers Suppliers

Magnesium Gluconate
BP USP FCC Food Grade
Magnesium gluconate

Magnesium Gluconate CAS Number 3632-91-5 or (59625-89-7 for hydrate), Molecular Formula: C12H22MgO14, Molecular Weight: 414.6

Magnesium Gluconate FCC Food Grade Specifications
[CH2OH(CHOH)4COO]2Mg
C12H22MgO14 Formula wt, anhydrous 414.60
C12H22MgO14ยท2H2O Formula wt, dihydrate 450.63
INS: 580 CAS: anhydrous [3632-91-5]
CAS: dihydrate [59625-89-7]

DESCRIPTION
Magnesium Gluconate occurs as a white to off white powder or granulate. It is anhydrous, the dihydrate, or a mixture of both. It is very soluble in water and is sparingly soluble in alcohol. It is insoluble in ether.

REQUIREMENTS
Identification
A. A 1:20 aqueous solution gives positive tests for Magnesium.
B. Chromatography Test.
Assay: Not less than 98.0% and not more than 102.0% of C12H22MgO14, calculated on the anhydrous basis.
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: Between 3.0% and 12.0%.


Magnesium Gluconate BP Ph Eur Grade Specifications
C12H22MgO14,xH2O -- 414.6 -- CAS 3632-91-5 (anhydrous)

DEFINITION
Anhydrous or hydrated magnesium D-gluconate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, amorphous, hygroscopic, crystalline or granular powder.
Solubility: Freely soluble in water, slightly soluble in ethanol (96 per cent), very slightly soluble in methylene chloride.

IDENTIFICATION
A. Thin-layer chromatography.
B. To 10 ml of solution S (see Tests) add 3 ml of ammonium chloride solution. A slight opalescence may be observed. Add 10 ml of disodium hydrogen phosphate solution. A white precipitate is formed that does not dissolve upon the addition of 2 ml of dilute ammonia.

TESTS
Solution S: Dissolve 1.0 g in water R and dilute to 50 ml with the same solvent.
Appearance of solution: Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y7 (2.2.2, Method II).
Sucrose and reducing sugars: Dissolve 0.5 g in a mixture of 2 ml of hydrochloric acid R1 and 10 ml of water R. Boil for 5 min, allow to cool, add 10 ml of sodium carbonate solution R and allow to stand for 10 min. Dilute to 25 ml with water and filter. To 5 ml of the filtrate add 2 ml of cupri-tartaric solution and boil for 1 min. Allow to stand for 2 min. No red precipitate is formed.
Chlorides: Maximum 500 ppm.
Sulphates: Maximum 500 ppm.
Heavy metals: Maximum 10 ppm.
Water: Maximum 12.0 per cent, determined on 80 mg.
Microbial contamination: Total viable aerobic count (2.6.12) not more than 103 micro-organisms per gram, determined by plate count.


Magnesium Gluconate USP Grade
C12H22MgO14xH2O -- (anhydrous) 414.60
D-Gluconic acid, magnesium salt (2:1), hydrate.
Magnesium D-gluconate (1:2) hydrate.
Magnesium D-gluconate (1:2) dihydrate 450.64 [CAS 59625-89-7].
Anhydrous [CAS 3632-91-5].

Magnesium Gluconate contains not less than 98.0 percent and not more than 102.0 percent of C12H22MgO14, calculated on the anhydrous basis.

Identification:
A: A solution (1 in 10) responds to the tests for Magnesium.
B: Chromatographic plate test.
pH: between 6.0 and 7.8, in a solution (1 in 20).
Water: between 3.0% and 12.0%.
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 1.0 mL of 0.020 N sulfuric acid (0.05%).
Heavy metals: the limit is 0.002%.
Reducing substances: the limit is 1.0%.

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Copyright Last 14 March, 2022

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