Calcium Levulinate USP BP Ph Eur EP Grade Manufacturers

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Calcium Levulinate Anhydrous and Dihydrate USP BP Ph Eur EP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Calcium Levulinate Anhydrous & Dihydrate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

Synonyms: Pentanoic acid, 4-oxo-, calcium salt (2:1)
CAS Number: 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous, Molecular Weight: 306.32 for Dihydrate and 270.30 Anhydrous, Chemical Formula: C10-H14-Ca-O6-(H2O)2 for Dihydrate and C10-H14-Ca-O6 for Anhydrous, EINECS EC Number: 209-725-9, FEMA: ----,

Calcium Levulinate USP Grade Specifications
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.

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 EDTA 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 EDTA disodium is equivalent to 13.51 mg of C10H14CaO6.

Calcium Levulinate Dihydrate BP Ph Eur Grade Specifications
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 identification, D, E.
Second identification, C, D, E.
A. Infrared absorption spectrophotometry comparison 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 Î¼l.
Development: Over a path of 10 cm.
Drying: At 100-105C 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 100-105C. 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.

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 EDTA is equivalent to 27.03 mg of C10H14CaO6.

Keywords: Pentanoic acid, 4-oxo-, calcium salt, Calcium Levulinate Dihydrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 5743-49-7 for Dihydrate and 591-64-0 for Anhydrous Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
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Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

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