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Calcium Levulinate Specifications of Commercial Pure & BP Ph Eur USP Grade Manufacturers & Exporters

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Calcium Levulinate Suppliers Manufacturers
Calcium Levulinate CAS Number 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous

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

DEFINITION
Calcium Levulinate contains NLT 97.5% and NMT 100.5% of calcium levulinate (C10H14CaO6), calculated on the dried basis.

IDENTIFICATION
A. Identification Tests-General, Calcium: A 100 mg/mL solution meets the requirements.
B.
Sample solution: 0.5 g in 5 mL of water
Analysis: To the Sample solution add 5 mL of 1 N sodium hydroxide, and filter. To the filtrate add 5 mL of iodine.
Acceptance criteria: A precipitate of iodoform is produced.

Chloride and Sulfate, Chloride:
Standard: 1.0 mL of 0.020 N hydrochloric acid
Sample: 1.0 g
Acceptance criteria: NMT 0.07%
Chloride and Sulfate, Sulfate:
Standard: 1.0 mL of 0.020 N sulfuric acid
Sample: 2.0 g
Acceptance criteria: NMT 0.05%
Reducing Sugars:
Sample: 0.50 g
Analysis: Dissolve the Sample in 10 mL of water, add 2 mL of 3 N hydrochloric acid, boil for about 2 min, and cool. Add 5 mL of sodium carbonate, allow to stand for 5 min, dilute with water to 20 mL, and filter. Add 5 mL of the clear filtrate to 2 mL of alkaline cupric tartrate, and boil for 1 min.
Acceptance criteria: No red precipitate is formed immediately.
Melting Range or Temperature: 119C to 125C
pH:
Sample solution: 100 mg/mL
Acceptance criteria: 7.0 to 8.5
Loss on Drying: Dry a sample at a pressure not exceeding 5 mm of mercury at 60C for 5 h: it loses 10.5% to 12.0% of its weight.

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 identification A, D, E.
Second identification B, C, D, E.
A. Infrared absorption spectrophotometry comparison calcium levulinate dihydrate CRS.
B. Thin-layer chromatography. To pass te test
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 100C-105C. The melting point is 203C to 210C.
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±50C. 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 105C.
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.

SDS MSDS of Calcium Levulinate BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers

Crystal Clear Products and the group companies are manufacturing chemicals since several decades. We have automatic vacuum operated titanium evaporators and SS316 equipments to produce top grade of chemical products. We have toll manufacturers and representatives in China, UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Bangkok Thailand, Kaula Lumpur Malaysia, Dubai UAE etc. & sales representative in Chicago, Houston New York & Los Angeles, USA. Associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified, Crisil Rated.

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Crystal Clear Products
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

e-mail: info@crystalclearproducts.org

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