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Calcium Gluconate USP IP Pure AR LR ACS Analytical Reagent FCC Food Grade Manufacturers, SDS MSDS Sheet

Calcium Gluconate CAS Number 299-28-5 (or 18016-24-5 for monohydrate), EINECS EC Number 206-075-8, HS Code ---**; Molecular Weight 430.37, Molecular Formula: C12H22CaO14 (It has a monohydrate version apart from anhydrous grade)

For MSDS Sheet Click
MSDS Sheet of Calcium Gluconate Manufacturers

Calcium Gluconate
Commercial USP IP Pure LR AR ACS Analytical Reagent Grade
Calcium Gluconate

Calcium gluconate is a mineral supplement. It is manufactured by the neutralization of gluconic acid with lime or calcium carbonate. It is an effective non-toxic calcium supplement.

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.

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 IP Grade

----

Calcium Gluconate FCC Food Grade
CH2OH(CHOH)4COO 2Ca
C12H22CaO14 Formula wt, anhydrous 430.38
C12H22CaO14·H2O Formula wt, 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 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.

Function: Firming agent; stabilizer; texturizer.

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%.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

Manufacturers:

MUBY CHEMICALS
S-8, SARIFA MANSION, 2ND FLANK ROAD, CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE) 91-22-23770100, 23726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA & Canadian Customers may
e-mail: usa@mubychem.com
Call toll-free 1-844-682-9243 (1-844-MUBYCHEM)

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Last : 22 March, 2017

List of All the IP BP USP FCC ACS Grades of Chemicals
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Calcium Gluconate Calcium Hydroxide
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Ferric Chloride  
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Magnesium Chloride Magnesium Gluconate
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Magnesium Trisilicate Maleic Acid
Malic Acid BP USP Manganese Gluconate
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Methylene Blue Potassium Bromide
Potassium Chloride Potassium Gluconate
Potassium Bitartrate, Cream of Tartar Potassium Hydroxide
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Sodium Caprylate Sodium Fluoride
Sodium Gluconate Sodium Hydroxide Pellets
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Calcium Gluconate SDS MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name: Calcium Gluconate
Synonym:
2,3,4,5,6-Pentahydroxycaproic Acidhemicalcium salt, Gluconic acidhemicalcium salt, Calcium D-gluconate
Chemical Formula: C12H22CaO14 · H2O for monohydrate; C12H22CaO14 for anhydrous.
Molecular Weight: 448.39 for monohydrate; 430.37 for anhydrous
CAS Number: monohydrate 18016-24-5; anhydrous 299-28-5
EINECS EC Code: 206-075-8
Intended Use: Industrial Manufacturing
Supplier: As per letterhead.

Section 2: Hazards Identification

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Labeling according to GHS & Regulation (EC) No 1272/2008

GHS Label Elements
NONE

Signal Word: None

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

OSHA Hazards: No known OSHA hazards.

Section 3: Composition and Information on Ingredients

Name: Calcium Gluconate
CAS Number: monohydrate 18016-24-5; anhydrous 299-28-5
EINECS EC Code: 206-075-8

Section 4: First Aid Measures

Always seek medical advice after the first aid treatment.

Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Notes to Physician: Treat symptomatically.

Section 5: Fire and Explosion Data

Flammability of the Product: Non-flammable.
Auto-Ignition Temperature: Not applicable.
Flash Points: Not applicable.
Flammable Limits: Not applicable.
Products of Combustion: Calcium oxide, Fumes and Oxides of carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Section 6: Accidental Release Measures

Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Do not inhale vapors, mist, or gas. Avoid dust formation. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. Be careful that the product is not present at a concentration level above TLV. Check TLV with local authorities.

Section 7: Handling and Storage

Precautions: Do not breathe dust. Keep away from incompatibles such as oxidizing agents, acids.
Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.

Section 8: Exposure Controls/Personal Protection

Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.
Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent Gloves.
Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid white to off-white powder or granules.
Odor: Odorless.
Chemical Formula: C12H22CaO14 · H2O for monohydrate; C12H22CaO14 for anhydrous.
Molecular Weight: 448.39 for monohydrate; 430.37 for anhydrous
pH (5% soln/water): 6 to 7.
Boiling Point: Not available.
Melting Point: Not available.
Decomposition temperature : 100°C
Solubility: Soluble in cold water.

Section 10: Stability and Reactivity Data

Stability: It is stable.
Conditions of instability: Incompatible materials
Incompatibility with various substances: Heat, light, strong oxidizing agents, bases, amines, reducing agents, acids, acid anhydrides.
Polymerization: Will not occur.

Section 11: Toxicological Information

Toxicity to Animals: LD50 Intravenous - rat - 950 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.

Section 12: Ecological Information

Ecotoxicity: The product is not considered harmful to aquatic organisms or to cause long-term adverse effects in the environment. Not dangerous for the ozone layer.
Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT (US): Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods

Section 15: Other Regulatory Information

USA Federal and State Regulations:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

HMIS (Perceived): Health Hazard: 0, Fire Hazard: 0, Reactivity: 0
NFPA (Perceived): Health: 0, Flammability: 0, Reactivity: 0

Canada WHMIS Hazard Class: Non-controlled

EINECS EC Code: 206-075-8

Section 16 - Additional Information

DISCLAIMER: The information and recommendations set forth herein (hereinafter "Information") are presented in good faith and believed correct as of the date hereof. It is compiled from various sources and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.