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Calcium Gluceptate BP USP Grade Manufacturers, SDS GHS MSDS Sheet

Calcium Gluceptate: CAS Number: 29039-00-7 (also 17140-60-2), EINECS EC Number: yyyyy, Molecular Formula: C14H26CaO16, Molecular Weight: 490.42, HS Code ---**

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Calcium Gluceptate
BP USP
Calcium Gluceptate

Calcium Glucoheptonate BP Grade
Ph Eur
C14H26CaO16 -- 490.4 -- 29039-00-7
Action and use: Used in treatment of calcium deficiency.

DEFINITION
Mixture in variable proportions, of calcium di(D-glycero-D-gulo-heptonate) and calcium di (D-glycero-D-ido-heptonate).
Content: 98.0 per cent to 102.0 per cent of calcium 2,3,4,5,6,7-hexahydroxyheptanoate (dried substance).

CHARACTERS
Appearance: White or very slightly yellow, amorphous powder, hygroscopic.
Solubility: Very soluble in water, practically insoluble in acetone and in ethanol (96 per cent).

IDENTIFICATION
A. Thin-layer chromatography.
B. 0.2 ml of (see Tests) gives reaction (b) of calcium.

TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
pH: 6.0 to 8.0 for solution S.
Reducing sugars: Maximum 1 per cent, expressed as glucose.
Cyanide: To pass the test.
Chlorides: Maximum 100 ppm.
Sulphates: Maximum 100 ppm, determined on solution S.
Iron: Maximum 40 ppm.
Heavy metals: Maximum 10 ppm.
Loss on drying: Maximum 5.0 per cent, determined on 1.000 g by drying in an oven at 105C for 3 h.
Bacterial endotoxins: Less than 167 IU/g, if intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins.
ASSAY: Dissolve 0.800 g in a mixture of 150 ml of water and 2 ml of 3 M hydrochloric acid . While stirring, add 12.5 ml of 0.1 M sodium edetate , 15 ml of 1 M sodium hydroxide and 0.3 g of hydroxynaphthol blue, sodium salt. Titrate with 0.1 M sodium edetate until the colour changes from violet to pure blue.
1 ml of 0.1 M sodium edetate is equivalent to 49.04 mg of C14H26CaO16.


Calcium Gluceptate USP Grade
C14H26CaO16 (anhydrous) -- 490.42
Glucoheptonic acid, calcium salt (2:1).
Calcium glucoheptonate (1:2) -- [29039-00-7].

Calcium Gluceptate is anhydrous or contains varying amounts of water of hydration. It consists of the calcium salt of the alpha epimer of glucoheptonic acid or of a mixture of the alpha and beta epimers of glucoheptonic acid. It contains not less than 95.0 percent and not more than 102.0 percent of C 14H26CaO16, calculated on the dried basis.

Labeling: Label it to indicate whether it is hydrous or anhydrous; if hydrous, label it to indicate also the degree of hydration.

Identification:
A: Infrared Absorption 197K .
B: A solution (1 in 50) responds to the tests for Calcium 191 .
pH: between 6.0 and 8.0, in a solution (1 in 10).
Loss on drying: [NOTE—The quantity taken for the determination may be adjusted, if necessary, for instrument sensitivity. Weight loss occurring at temperatures above about 160 degree indicative of decomposition, is not to be interpreted as Loss on drying.] Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument, using 10 to 25 mg of Calcium Gluceptate accurately weighed. Heat the specimen under test at a rate of 5 degrees per minute in an atmosphere of nitrogen, at a flow rate of 40 mL per minute. Record the thermogram to 150 degree: the anhydrous form loses not more than 1.0%, the 2H2O form not more than 6.9%, and the 3½H2O form not more than 11.4%, of its weight.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 1.0 mL of 0.020 N hydrochloric acid (0.07%).
Sulfate: A 2.0-g portion shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (0.05%).
Heavy metals: Dissolve 1 g in 25 mL of water: the limit is 0.002%.
Reducing sugars: Dissolve 0.50 g in 10 mL of hot water, add 2 mL of 3 N hydrochloric acid, boil for about 2 minutes, and cool. Add 5 mL of sodium carbonate, allow to stand for 5 minutes, dilute with water to 20 mL, and filter. Add 5 mL of the clear filtrate to about 2 mL of alkaline cupric tartrate and boil for 1 minute: no red precipitate is formed immediately.
Assay: Dissolve about 800 mg of Calcium Gluceptate, accurately weighed, in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring, preferably with a magnetic stirrer, add about 25 mL of 0.05 M edetate disodium from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 24.52 mg of C14H26CaO16.

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
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) 91-22-23770100, 23726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

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Call toll-free 1-844-682-9243 (1-844-MUBYCHEM)

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Last : 8 August, 2017

List of All the IP BP USP FCC ACS Grades of Chemicals
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Calcium Gluconate Calcium Hydroxide
Calcium Lactate Calcium Oxide
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Chromic Chloride Citric Acid
Calcium Citrate Copper Gluconate
Copper Sulfate, Cupric Sulphate Cupric Chloride
Ferrous Fumarate Ferrous Gluconate
Fumaric Acid Ferrous Sulphate
Ferric Sulfate Ferric Ammonium Citrate
Ferric Chloride  
Gentian Violet Mannitol
Magnesium Chloride Magnesium Gluconate
Magnesium Lactate Dihydrate Magnesium Sulfate
Magnesium Trisilicate Maleic Acid
Malic Acid BP USP Manganese Gluconate
Manganese Sulfate Manganese Chloride
Methylene Blue Potassium Bromide
Potassium Chloride Potassium Gluconate
Potassium Bitartrate, Cream of Tartar Potassium Hydroxide
Potassium Iodide Potassium Iodate
Potassium Sorbate Sodium Acetate
Sodium Bicarbonate Sodium Butyrate
Sodium Caprylate Sodium Fluoride
Sodium Gluconate Sodium Hydroxide Pellets
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Sodium Thiosulfate Sodium Sulfate
Stannous Chloride Dihydrate Zinc Carbonate
Zinc Chloride Zinc Gluconate
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Calcium Gluceptate or Calcium Glucoheptonate SDS MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name: Calcium Gluceptate or Calcium Glucoheptonate
Synonym:
Calcium glucoheptonate, Glucoheptonic acid, calcium.
Chemical Formula: C14H26CaO16.
Molecular Weight: 490.42
CAS Number: 29039-00-7 (also quoted is 17140-60-2)
EINECS EC Code: --
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 mild 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.

Section 3: Composition and Information on Ingredients

Name: Calcium Gluceptate or Calcium Glucoheptonate
CAS Number: 29039-00-7 (also quoted is 17140-60-2)
EINECS EC Code: NA

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: Like all organic substances it can catch fire at elevated temperature.
Auto-Ignition Temperature: Not known.
Flash Points: 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.
Odor: Not available.
Chemical Formula: C14H26CaO16.
Molecular Weight: 490.42
pH (5% soln/water): Not available.
Boiling Point: Not available.
Melting Point: Not available.
Decomposition temperature : 200°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: Not available.
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:
No information found.

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: Not available

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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