Carmellose Calcium

Carboxymethylcellulose Calcium USP Grade Specifications:
Cellulose, carboxymethyl ether, calcium salt;
Cellulose carboxymethyl ether calcium salt CAS 9050-04-8
UNII: UTY7PDF93L

DEFINITION
Carboxymethylcellulose Calcium is the calcium salt of a polycarboxymethyl ether of cellulose.

IDENTIFICATION
A. Procedure
Sample solution: Shake thoroughly 0.1 g of Carboxymethylcellulose Calcium with 10 mL of water, followed by 2 mL of 1 N sodium hydroxide, and allow to stand for 10 min. [Note— Save the unused portion of the Sample solution for use in Identification tests B and C.]
Analysis: To 1 mL of the Sample solution add water to make 5 mL. To 1 drop of the resulting solution, add 0.5 mL of chromotropic acid, and heat in a water bath for 10 min.
Acceptance criteria: A red-purple color develops.
B. Procedure
Analysis: Shake 5 mL of the Sample solution prepared in Identification test A with 10 mL of acetone.
Acceptance criteria: A white, flocculent precipitate is formed.
C. Procedure
Analysis: Shake 5 mL of the Sample solution prepared in Identification test A with 1 mL of ferric chloride.
Acceptance criteria: A brown, flocculent precipitate is formed.
D. Identification Tests—General:
Analysis: Ignite 1 g to ash, dissolve the residue in 10 mL of water and 5 mL of 6 N acetic acid, and filter, if necessary. Boil the filtrate, cool, and neutralize with 6 N ammonium hydroxide.
Acceptance criteria: Meets the requirements.

Residue on Ignition: 10.0%–20.0%; use 1.0 g, previously dried.
Chloride and Sulfate: To pass the test.
Chloride and Sulfate: To pass the test.
Alkalinity: Shake thoroughly 1.0 g with 50 mL of freshly boiled and cooled water and add 2 drops of phenolphthalein: no red color develops.
Loss on Drying: Dry a sample at 105C for 4 h: it loses NMT 10.0% of its weight.

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Carmellose Calcium BP Grade
Ph Eur --- 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.

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Certifications :
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