Calcium Gluconate USP EP BP IP FCC Food Grade Manufacturers

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Calcium Gluconate USP EP BP IP FCC Food Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Calcium Gluconate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

Synonyms: D-Gluconic acid, calcium salt, Calcium D-gluconate
CAS Number: 299-28-5 anhydrous, (18016-24-5 monohydrate), Molecular Weight: 430.37, Chemical Formula: C12H22CaO14, EINECS EC Number: 206-075-8, FEMA: ----,

Calcium Gluconate USP Grade Specifications
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%.

Calcium Gluconate BP Grade Ph Eur Grade Specifications
C12H22CaO14,H2O --- 448.4 --- CAS 18016-24-5

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 60C, 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.

Calcium Gluconate FCC Food Grade Specifications
CH2OH(CHOH)4COO 2Ca
C12H22CaO14 Formula weight, anhydrous 430.38
C12H22CaO14-H2O Formula weight, monohydrate 448.39
CAS: anhydrous 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 25C 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%.

Keywords: D-Gluconic acid calcium salt, Calcium D-gluconate, Calcium Gluconate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 299-28-5 anhydrous 18016-24-5 monohydrate Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

Exporters to USA, Canada, UAE, Kwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnak, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.

Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.