Calcium Gluceptate or Calcium Glucoheptonate BP Ph Eur EP USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Calcium Gluceptate or Calcium Glucoheptonate BP Ph Eur EP, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail prices, Uses etc available on these pages for Calcium Gluceptate or Calcium Glucoheptonate .

Calcium Glucoheptonate BP Ph Eur 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.

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Calcium Gluceptate or Calcium Glucoheptonate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 05-Oct-20

Product Name & Other Names: Calcium gluceptate or Calcium glucoheptonate or Glucoheptonic acid, calcium.
CAS Number: 29039-00-7 (also quoted is 17140-60-2)
EINECS EC Code: --
Chemical Formula: C14H26CaO16.
Molecular Weight: 490.42
Relevant uses and uses advised against (if any): Industrial Manufacturing
Supplier: As per letterhead.

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.

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.

Product Name & Other Names: Calcium gluceptate or Calcium glucoheptonate or Glucoheptonic acid, calcium.
CAS Number: 29039-00-7 (also quoted is 17140-60-2)

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.

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.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.

Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage:
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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents, bases, amines, reducing agents, acids, acid anhydrides.

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.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance: Solid
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature : 200C
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in cold water.
Viscosity: Not available.
Chemical Formula: C14H26CaO16.
Molecular Weight: 490.42

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.

Toxicity to Animals: Not available.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

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.
Persistence and Degradability: Unlikely to persist due to water solubility.
Mobility: Likely to be mobile due to water solubility.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

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

DOT USA & ADR/RID Europe: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods.

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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