Calcium Gluconate Manufacturers Suppliers

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Calcium Gluconate USP IP BP FCC Food Grade Manufacturers Suppliers

Calcium Gluconate CAS Number: 299-28-5 (or 18016-24-5 for monohydrate), Molecular Formula: C12H22CaO14, Molecular Weight: 430.37

Calcium Gluconate FCC Food Grade Specifications
CH2OH(CHOH)4COO 2Ca
C12H22CaO14 Formula weight, anhydrous 430.38
C12H22CaO14·H2O Formula wt, monohydrate 448.39
CAS: anhydrous [CAS 299-28-5]
INS: 578

DESCRIPTION
Calcium Gluconate occurs as white, crystalline granules or powder. It is anhydrous or contains one molecule of water of hydration. It is stable in air. One gram dissolves slowly in about 30 mL of water at 25° and in about 5 mL of boiling water. It is insoluble in alcohol and in many other organic solvents. Its solutions are neutral to litmus.

REQUIREMENTS
Identification:
A. A 1:50 aqueous solution gives positive tests for Calcium.
B. Chromatographic test.
Assay: Anhydrous: Not less than 98.0% and not more than 102.0% of C12H22CaO14, calculated on the dried basis; Monohydrate: Not less than 98.0% and not more than 102.0% of
C12H22CaO14·H2O, calculated on the as-is basis.
Lead: Not more than 2 mg/kg.
Loss on Drying: Anhydrous: Not more than 3.0%; Monohydrate: Not more than 2.0%.
Sucrose and Reducing Sugars: Not more than 1.0%.

C12H22CaO14 (anhydrous) 430.37
D-Gluconic acid, calcium salt (2:1).
Calcium D-gluconate (1:2) [CAS 299-28-5].
Monohydrate 448.39

Calcium Gluconate is anhydrous or contains one molecule of water of hydration. The anhydrous form contains not less than 98.0 percent and not more than 102.0 percent of C12H22CaO14, calculated on the dried basis. The monohydrate form contains not less than 99.0 percent and not more than 101.0 percent of C12H22CaO14H2O where labeled as intended for use in preparing injectable dosage forms, and not less than 98.5 percent and not more than 102.0 percent of C12H22CaO14H2O where not intended for use in
preparing injectable dosage forms.

Identification—
A: A solution (1 in 50) responds to the test for Calcium.
B: Chromatographic plate test.
Loss on drying: Dry it at 105 for 16 hours: the anhydrous form loses not more than 3.0% of its weight; the monohydrate form, where labeled as intended for use in preparing injectable dosage forms, loses not more than 1.0% of its weight, and where not intended for use in preparing injectable dosage forms loses not more than 2.0% of its weight.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 0.07 mL of 0.020 N hydrochloric acid (0.005%). Where it is not intended for use in the preparation of injectable dosage forms, a 1.0-g portion shows no more chloride than corresponds to 1 mL of 0.020 N hydrochloric acid (0.07%).
Limit of oxalate: Calcium Gluconate not intended for use in the preparation of injectable dosage forms is exempt from this requirement. For details please see the original monograph.
Limit of phosphate: To pass the test.
Sulfate: To pass the test.
Arsenic: The limit is 3 ppm.
Heavy metals: 0.001%. [Where Calcium Gluconate not intended for use in the preparation of injectable dosage forms, the limit is 0.002%.]
Limit of magnesium and alkali metals: (0.4%). [NOTE—Calcium Gluconate not intended for use in preparing injectable dosage forms is exempt from this requirement.]
Limit of iron: The limit is 5 ppm. [NOTE—Calcium Gluconate labeled as not intended for use in the preparation of injectable dosage forms is exempt from this requirement.]
Reducing substances: the limit is 1.0%.

DEFINITION
Calcium D-gluconate monohydrate.
Content: 98.5 per cent to 102.0 per cent of C12H22CaO14,H2O.

CHARACTERS
Appearance: White or almost white, crystalline or granular powder.
Solubility: Sparingly soluble in water, freely soluble in boiling water.

IDENTIFICATION
A. Thin-layer chromatography.
B. Solution S (see Tests) gives the reactions of calcium.

TESTS
Solution S: Dissolve 1.0 g in water R heated to 60 °C and dilute to 50 ml with the same solvent.
Appearance of solution: At 60 °C, solution S is not more intensely coloured than reference solution. After cooling, it is not more opalescent than reference suspension.
Organic impurities and boric acid: To pass the test.
Sucrose and reducing sugars: To pass the test.
Chlorides: Maximum 200 ppm.
Sulphates: Maximum 100 ppm.
Magnesium and alkali metals: Maximum 0.4 per cent.
Heavy metals: Maximum 10 ppm.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate count.

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