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Calcium Levulinate BP USP Grade Manufacturers, SDS GHS MSDS Sheet

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 ---**

For MSDS Sheet Click
SDS MSDS Sheet of Calcium Levulinate Manufacturers

Calcium Levulinate
Pure BP USP Grade
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 [5743-49-7].
Anhydrous 270.30 [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 -- 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.

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

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Last : 22 March, 2017

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Sodium Gluconate Sodium Hydroxide Pellets
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Calcium Levulinate SDS MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Identification

Product Name: 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
Chemical Formula: C10-H14-Ca-O6-(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous
Intended Use: Laboratory and 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

Not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200)

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.

Section 3: Composition and Information on Ingredients

Composition: Calcium Levulinate
CAS#: 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous
EINECS EC-No.: 209-725-9
% by Weight: 100

Section 4: First Aid Measures

Always seek medical attention after first aid measures are provided.

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.

Section 5: Fire and Explosion Data

Flammability of the Product: Calcium Levulinate 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.

Section 6: Accidental Release Measures

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: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow drain.

Section 7: Handling and Storage

Precautions: Keep away from heat. Keep away from sources of ignition. Do not breathe dust.
Storage: Keep Calcium Levulinate container tightly closed. Keep container in a cool, well-ventilated area.

Section 8: Exposure Controls/Personal Protection

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.
Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Exposure Limits: Not available.

Section 9: Physical and Chemical Properties

Physical state and appearance: Calcium Levulinate is solid. amorphous or crystalline powder.)
Odor: Burnt Sugar Type..
Taste: Not available.
Chemical Formula: C10-H14-Ca-O6-(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous
Color: White to off-white.
pH (1% soln/water): Not available.
Melting Point: 123C
Solubility: Soluble in water.

Section 10: Stability and Reactivity Data

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.

Section 11: Toxicological Information

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.

Section 12: Ecological Information

Ecotoxicity: Not available.
Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.
Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Section 13: Disposal Considerations

Waste Disposal: Waste must be disposed of in accordance legal regulations.

Section 14: Transport Information

DOT (US): Not dangerous goods
ADR/RID: Not dangerous goods
TDG/IMDG: Not dangerous goods
IATA: Not dangerous goods

Section 15: Other Regulatory Information

USA:
Toxic Substance Control Act (TSCA 8b.): This product is ON the EPA Toxic Substances Control Act (TSCA) inventory.
SARA 313: Not Listed
SARA 302: Not Listed

State Right-to-Know:
Massachusetts: Not Listed
New Jersey: Not Listed
Pennsylvania: Not Listed
California Proposition 65: Not Listed

HMIS (Perceived): Health Hazard: 1; Fire Hazard: 1; Reactivity: 0; Personal Protection: E
NFPA (Perceived): Health: 1; Flammability: 1; Reactivity: 0

Canada WHMIS: Not controlled under WHMIS (Canada).
Canadian Domestic Substances List (DSL): Not Listed
Canadian Domestic Substances List (NDSL): Listed

EINECS EC-No.: 209-725-9

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.