Calcium Levulinate EP IP BP USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Calcium Levulinate IP EP BP USP Grade, 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, Peru, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Calcium Levulinate: CAS Number: 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous, EINECS EC Number: 209-725-9, Molecular Formula: C10-H14-Ca-O6•(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous, Molecular Weight: 306.32 for Dihydrate and 270.30 Anhydrous, HS Code ---**

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

Calcium Levulinate is a calcium compound used parenterally in the treatment of hypocalcemia; contains 14.8% calcium. It is a hydrated calcium salt of levulinic acid. It has the usual effects of calcium administered orally or intravenously.

Calcium Levulinate USP Grade
C10H14CaO6.2H2O -- 306.32
Pentanoic acid, 4-oxo-, calcium salt (2:1), dihydrate.
Calcium levulinate (1:2) dihydrate [CAS 5743-49-7].
Anhydrous 270.30 [CAS 591-64-0].

Calcium Levulinate contains not less than 97.5 percent and not more than 100.5 percent of C10H14CaO6, calculated on the dried basis.
Packaging and storage: Preserve in well-closed containers.

Identification—
A: A solution (1 in 10) responds to the tests for Calcium.
B: To a solution of 0.5 g in 5 mL of water add 5 mL of 1 N sodium hydroxide, and filter. To the filtrate add 5 mL of iodine: a precipitate of iodoform is produced.

Melting range: between 119 and 125 .
pH: between 7.0 and 8.5, in a solution (1 in 10).
Loss on drying: Dry it at a pressure not exceeding 5 mm of mercury at 60 for 5 hours: it loses between 10.5% and 12.0% 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: 0.002%.
Reducing sugars: Dissolve 0.50 g in 10 mL of 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 600 mg of Calcium Levulinate, accurately weighed, in 150 mL of watercontaining 2 mL of 3 N hydrochloric acid. While stirring with a magnetic stirrer, add 30 mL of 0.05 M edetate disodium from a 50-mL buret, followed by 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to the blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 13.51 mg of C10H14CaO6.

Calcium Levulinate Dihydrate BP Grade
Ph Eur
C10H14CaO6,2H2O -- 306.3 -- CAS 5743-49-7
Action and use: Source of calcium.

DEFINITION
Calcium di(4-oxopentanoate) dihydrate.
Content: 98.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.

IDENTIFICATION
First identificationı A, D, E.
Second identificationı B, C, D, E.
A. Infrared absorption spectrophotometry comparisonı calcium levulinate dihydrate CRS.
B. Thin-layer chromatography.
Test solution: Dissolve 60 mg of the substance to be examined in water and dilute to 1 ml with the same solvent.
Reference solution: Dissolve 60 mg of calcium levulinate dihydrate CRS in water and dilute to 1 ml with the same solvent.
Plate: TLC silica gel plate.
Mobile phase: concentrated ammonia, ethyl acetate, water, ethanol (96 per cent) (10:10:30:50 V/V/V/V).
Application: 10 μl.
Development: Over a path of 10 cm.
Drying: At 100-105 °C for 20 min and allow to cool.
Detection: Spray with a 30 g/l solution of potassium permanganate. Dry in a current of warm air for about 5 min or until the spots become yellow. Examine in daylight.
Results: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.
C. To 1 ml of solution S (see Tests), add 20 ml of a 2.5 g/l solution of dinitrophenylhydrazine in dilute hydrochloric acid. Allow to stand for 15 min. Filter, wash the precipitate with water. Dry the precipitate in an oven at 100-105 °C. The melting point is 203 °C to 210 °C.
D. It gives reaction of calcium.
E. Loss on drying (see Tests).

TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water and dilute to 100.0 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
pH: 6.8 to 7.8 for solution S.
Oxidisable substances: To 1 ml of solution S, add 10 ml of water, 1 ml of dilute sulphuric acid and 0.25 ml of a 3.0 g/l solution of potassium permanganate. Mix. After 5 min, the violet colour of the mixture is still visible.
Sucrose and reducing sugars: To 5 ml of solution S add 2 ml of hydrochloric acid and dilute to 10 ml with water. Heat to boiling for 5 min and allow to cool. Add 10 ml of sodium carbonate solution. Allow to stand for 5 min, dilute to 25 ml with water and filter. To 5 ml of the filtrate add 2 ml of cupri-tartaric solution and heat to boiling for 1 min. No red precipitate is formed.
Chlorides: Maximum 50 ppm.
Sulphates: Maximum 200 ppm.
Magnesium and alkali metals: Maximum 1.0 per cent.
To 10 ml of solution S, add 80 ml of water, 10 ml of ammonium chloride solution R and 1 ml of ammonia. Heat to boiling. To the boiling solution, add drop-wise 50 ml of warm ammonium oxalate solution. Allow to stand for 4 h, then dilute to 200 ml with water and filter. To 100 ml of the filtrate, add 0.5 ml of sulphuric acid. Evaporate to dryness on a water-bath and ignite to constant mass at 600 ± 50 °C. The residue weighs a maximum of 5.0 mg.
Heavy metals: Maximum 10 ppm.
Loss on drying: 11.0 per cent to 12.5 per cent, determined on 0.200 g by drying at 105 °C.
Pyrogens: If intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of pyrogens, it complies with the test for pyrogens. Inject per kilogram of the rabbit's mass 4 ml of a solution containing per millilitre 50 mg of the substance to be examined.

ASSAY
Dissolve 0.240 g in 50 ml of water R . Carry out the complexometric titration of calcium. 1 ml of 0.1 M sodium edetate is equivalent to 27.03 mg of C10H14CaO6.

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Calcium Levulinate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 06-Oct-20

Product Name & Other Names: 3-Acetylpropionic acid calcium salt, Pentanoic acid, 4-oxo-, calcium salt
CAS#: 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous
EINECS EC-No.: 209-725-9
Molecular Weight: 306.32 for Dihydrate
Chemical Formula: C10-H14-Ca-O6-(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous
Relevant uses and uses advised against (if any): Laboratory and 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.
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: 3-Acetylpropionic acid calcium salt, Pentanoic acid, 4-oxo-, calcium salt
CAS#: 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous
EINECS EC-No.: 209-725-9

Eye Contact: In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention.
Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Thoroughly clean shoes and clothes before reuse. Get medical attention.
Inhalation: If Calcium Levulinate is inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately.

Flammability of the Product: May be combustible at high temperature.
Auto-Ignition Temperature: Not available.
Products of Combustion: Some metallic oxides CO CO2 and fumes.
Fire Hazards in Presence of Various Substances: Slightly flammable in presence of heat. Non-flammable in presence of shocks.
Explosion Hazards in Presence of Various Substances: Slightly explosive in presence of open flames and sparks. Non-explosive in presence of shocks.
Fire Fighting Media and Instructions:
Small Fire: Use DRY chemical powder.
Large Fire: Use water spray, fog, or foam. Avoid water jet.
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: Avoid dust formation. Avoid breathing vapors, mist, or gas. 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 authority 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.

Exposure Limits: Not established.
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.
Exposure Limits: Not available.

Appearance: White to off-white amorphous or crystalline powder
Odor: Burnt Sugar Type..
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting Point: 123C
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
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(ies): Not available.
Viscosity: Not available.
Molecular Weight: 306.32 for Dihydrate
Chemical Formula: C10-H14-Ca-O6-(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous.

Stability: It is stable.
Conditions of Instability: Excessive heat, dust generation
Incompatibility with various substances: Oxidizing Agents, heat and sunlight.
Special Remarks on Reactivity: Releases water of crystallization when heated and decomposes.
Hazardous decomposition products formed under fire conditions: Carbon oxides, Calcium oxide.
Polymerization: Will not occur.

Toxicity to Animals:
Oral-rat LD50: 6140 mg/kg
Oral Mouse LD50: 7,250 mg/kg
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Environmental Toxicity: Not available.

Toxicity data: Not available.
Products of Biodegradation: Possibly hazardous short-term degradation products are not likely. However, long term degradation products may arise.
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.

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

Section 15: Other Regulatory Information
USA:
SARA 313: Not Listed
SARA 302: Not Listed
California Proposition 65: Not Listed.

DISCLAIMER: The information and recommendations set forth herein 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.

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