Calcium Gluconate and Sodium Gluconate USP BP IP FCC Food Grade Manufacturers Exporters

Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Calcium Gluconate and Sodium Gluconate, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc.

Aadhunik Industries and/or associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified. We offer crystals granules in precise micron or mesh size as per buyers needs. We offer very high purity standards as per specifications required.

Calcium Gluconate BP Grade Ph Eur

C12H22CaO14,H2O --- 448.4 --- 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 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.

Calcium Gluconate USP Grade

C12H22CaO14 (anhydrous) 430.37
D-Gluconic acid, calcium salt (2:1).
Calcium D-gluconate (1:2) [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

C12H22CaO14,H2O --- 448.4 --- 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.

Sodium Gluconate USP
C6H11NaO7 -- 218.14
d-Gluconic acid, monosodium salt.
Monosodium d-gluconate [527-07-1].

Sodium Gluconate contains not less than 98.0 percent and not more than 102.0 percent of C6H11NaO7.

Identification:
A: A solution (1 in 20) responds to the tests for Sodium.
B: It responds to Identification test B under Calcium Gluconate.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 1 mL of 0.020 N hydrochloric acid (0.07%).
Sulfate: A 2.0-g portion dissolved in boiling water shows no more sulfate than corresponds to 1 mL of 0.020 N sulfuric acid (0.05%).
Lead: Dissolve 1.0 g in 25 mL of water: the limit is 0.001%.
Heavy metals: Dissolve 1.0 g in 10 mL of water, add 6 mL of 3 N hydrochloric acid, and dilute with water to 25 mL: the limit is 0.002%.
Reducing substances: Transfer 1.0 g to a 250-mL conical flask, dissolve in 10 mL of water, and add 25 mL of alkaline cupric citrate TS. Cover the flask, boil gently for 5 minutes, accurately timed, and cool rapidly to room temperature. Add 25 mL of 0.6 N acetic acid, 10.0 mL of 0.1 N iodine VS, and 10 mL of 3 N hydrochloric acid, and titrate with 0.1 N sodium thiosulfate VS, adding 3 mL of starch TS as the endpoint is approached. Perform a blank determination, omitting the specimen, and note the difference in volumes required. Each mL of the difference in volume of 0.1 N sodium thiosulfate consumed is equivalent to 2.7 mg of reducing substances (as dextrose): the limit is 0.5%.
Assay: Transfer about 150 mg of Sodium Gluconate, accurately weighed, to a suitable conical flask, and dissolve in 75 mL of glacial acetic acid, warming if necessary to effect complete solution. Cool, add quinaldine red TS, and titrate with 0.1 N perchloric acid VS to a colorless endpoint. Each mL of 0.1 N perchloric acid is equivalent to 21.81 mg of C6H11NaO7.

Sodium Gluconate FCC Food Grade
Sodium D-Gluconate
CH2OH(CHOH)4COONa
C6H11NaO7 Formula wt 218.14
CAS: [527-07-1]

DESCRIPTION
Sodium Gluconate occurs as a white to tan, granular to fine, crystalline powder. It is very soluble in water, and is sparingly soluble in alcohol. It is insoluble in ether.
Function: Nutrient; sequestrant.

REQUIREMENTS

Identification:
A. A 1:20 aqueous solution gives positive tests for Sodium.
B. 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 Potassium 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 110C for 20 min. 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 to volume with 2 N sulfuric acid, and mix. After spraying, heat the plate at 110C for about 10 min. The principal spot obtained from the Test Solution corresponds in color, size, and Rf value to that obtained from the Standard Solution.
Assay: Not less than 98.0% and not more than 102.0% of C6H11NaO7.
Lead: Not more than 2 mg/kg.
Reducing Substances: Not more than 0.5%, calculated as D-glucose.

CAS Number 299-28-5 (or 18016-24-5 for monohydrate & 527-07-1, Calcium Gluconate and Sodium Gluconate manufacturers suppliers exporters at:

manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.