Finoric LLC

Carmellose

Carmellose, Carmellose Calcium, Carmellose Sodium Pure & BP Grade Supplier, Manufacturer's Representative

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DESCRIPTION

Carmellose BP Grade
Ph Eur

DEFINITION
Polycarboxymethylether of cellulose.

CHARACTERS
Appearance:  White or almost white powder, hygroscopic.
Solubility: Practically insoluble in anhydrous ethanol. It swells with water to form a suspension  and becomes viscid in 1 M sodium hydroxide.

IDENTIFICATION
A. pH 3.5 to 5.0.
Suspend 1.0 g in 100 mL of water R.
B. Infrared absorption spectrophotometry

TESTS
Chlorides:  Maximum 0.36 per cent.
Sulfates:  Maximum 0.72 per cent.
Heavy metals:  Maximum 20 ppm.
Loss on drying:  Maximum 8.0 per cent, determined on 1.000 g by drying in an oven at 10C for 4 h.
Sulfated ash: Maximum 1.5 per cent, determined on 1.0 g.

Carmellose Calcium BP Grade
Ph Eur
CAS Number 9050-04-8

DEFINITION
Calcium salt of a partly O-carboxymethylated cellulose.

CHARACTERS
Appearance: White or yellowish-white powder, hygroscopic after drying.
Solubility: Practically insoluble in acetone, in alcohol and in toluene. It swells with water to form a suspension.

IDENTIFICATION
A. Shake 0.1 g thoroughly with 10 ml of water. Add 2 ml of dilute sodium hydroxide solution and allow to stand for 10 min (solution A). Dilute 1 ml of solution A to 5 ml with water. To 0.05 ml add 0.5 ml of a 0.5 g/l solution of chromotropic acid, sodium salt in a 75 per cent m/m solution of sulphuric acid and heat on a water-bath for 10 min. A reddish-violet colour develops.
B. Shake 5 ml of solution A obtained in identification test A with 10 ml of acetone. A white, flocculent precipitate is produced.
C. Shake 5 ml of solution A obtained in identification test A with 1 ml of ferric chloride solution. A brown, flocculent precipitate is formed.
D. Ignite 1 g and dissolve the residue in a mixture of 5 ml of acetic acid and 10 ml of water. Filter if necessary and boil the filtrate for a few minutes. Cool and neutralise with dilute ammonia. The solution gives reaction of calcium.

TESTS
Solution S: Shake 1.0 g with 50 ml of distilled water, add 5 ml of dilute sodium hydroxide solution and dilute to 100 ml with distilled water.
Alkalinity: Shake 1.0 g thoroughly with 50 ml of carbon dioxide-free water and add 0.05 ml of phenolphthalein solution R . No red colour develops.
Chlorides: Maximum 0.36 per cent.
Sulphates: Maximum 1 per cent.
Heavy metals: Maximum 20 ppm.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 105C for 4 h.
Sulphated ash: 10.0 per cent to 20.0 per cent, determined on 1.0 g in a platinum crucible.

Carmellose Sodium BP Grade
Ph Eur
CAS Number 9004-32-4

DEFINITION
Carmellose sodium (carboxymethylcellulose sodium) is the sodium salt of a partly Ocarboxymethylated cellulose. It contains not less than 6.5 per cent and not more than 10.8 per cent of sodium (Na), calculated with reference to the dried substance.

CHARACTERS
A white or almost white, granular powder, hygroscopic after drying, practically insoluble in acetone, in ethanol and in toluene. It is easily dispersed in water giving colloidal solutions.

IDENTIFICATION
A. To 10 ml of solution S (see Tests) add 1 ml of copper sulphate solution. A blue, cotton-like precipitate is formed.
B. Boil 5 ml of solution S for a few minutes. No precipitate is formed.
C. The solution prepared from the sulphated ash in the test for heavy metals gives the reactions of sodium.

TESTS
Solution S: Sprinkle a quantity of the substance to be examined equivalent to 1.0 g of the dried substance onto 90 ml of carbon dioxide-free water at 40C to 50C stirring vigorously. Continue stirring until a colloidal solution is obtained, cool and dilute to 100 ml with carbon dioxide-free water.
Appearance of solution: Solution S is not more opalescent than reference suspension and not more intensely coloured than reference solution.
pH: The pH of solution S is 6.0 to 8.0.
Apparent viscosity: While stirring, introduce a quantity of the substance to be examined equivalent to 2.00 g of the dried substance into 50 ml of water heated to 90C. For a product of low viscosity, use if necessary, the quantity required to give the concentration indicated on the label. Allow to cool, dilute to 100.0 ml with water and stir until dissolution is complete. Determine the viscosity using a rotating viscometer at 20C and a shear rate of 10s- 1. If it is impossible to obtain a shear rate of exactly 10s- 1, use a shear rate slightly higher and a rate slightly lower and interpolate. The apparent viscosity is not less than 75 per cent and not more than 140 per cent of the value stated on the label.
Sodium glycollate: To pass the test: (0.4 per cent)
Chlorides: Dilute 2 ml of solution S to 15 ml with water R . The solution complies with the limit test for chlorides (0.25 per cent).
Heavy metals: To the residue obtained in the determination of the sulphated ash, add 1 ml of hydrochloric acid and evaporate on a water-bath. Take up the residue in 20 ml of water. 12 ml of the solution complies with limit test A for heavy metals (20 ppm).
Loss on drying: Not more than 10.0 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulphated ash: 20.0 per cent to 33.3 per cent, determined on 1.0 g using a mixture of equal volumes of sulphuric acid and water and calculated with reference to the dried substance. These limits correspond to a content of 6.5 per cent to 10.8 per cent of sodium (Na).

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