C12H22O14Zn --- 455.68
Bis(D-gluconato-O1,O2) zinc.
Zinc D-gluconate (1:2) [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%).
C12H22ZnO14,xH2O --- 455.7 (anhydrous substance)
DEFINITION
Anhydrous or hydrated zinc D-gluconate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white, hygroscopic, crystalline powder.
Solubility: Soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride.
IDENTIFICATION
A. Thin-layer chromatography to pass the test.
B. Dissolve 0.1 g in 5 mL of water. Add 0.5 mL of potassium ferrocyanide solution. A white precipitate is formed that does not dissolve upon the addition of 5 mL of hydrochloric acid.
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 not more opalescent than reference suspension II and not more intensely coloured than reference solution.
Sucrose and reducing sugars: Dissolve 0.5 g in a mixture of 2 mL of hydrochloric acid and 10 mL of water. Boil for 5 min, allow to cool, add 10 mL of sodium carbonate solution 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.
Sulfates: Maximum 500 ppm.
Cadmium: Maximum 2 ppm.
Water: Maximum 12.0 per cent, determined on 80.0 mg.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
ASSAY
Dissolve 0.400 g in 5 mL of dilute acetic acid. Carry out the complexometric titration of zinc.
1 mL of 0.1 M sodium edetate is equivalent to 45.57 mg of C12H22ZnO14.
C12H22O14Zn Formula wt 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.
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%.
