Carboxymethylcellulose Sodium Tablets
» Carboxymethylcellulose Sodium Tablets contain an amount of sodium (Na) equivalent to not less than 6.5 percent and not more than 9.5 percent of the labeled amount of carboxymethylcellulose sodium.
Packaging and storage— Preserve in tight containers.
Identification— Digest a quantity of powdered Tablets, equivalent to about 1 g of carboxymethylcellulose sodium, with 50 mL of water until solution is virtually complete, and filter: the filtrate responds to the following tests.
A: To about 30 mL of the solution add 3 mL of hydrochloric acid: a white precipitate is formed.
B: To the remainder of the solution add an equal volume of barium chloride TS: a fine, white precipitate is formed.
C: The filtrate from Identification test A responds to the tests for Sodium 191.
Disintegration 701: 2 hours.
Uniformity of dosage units 905: meet the requirements.
Assay— Weigh and finely powder not less than 20 Tablets. Weigh accurately a portion of the powder, equivalent to about 500 mg of carboxymethylcellulose sodium, add 80 mL of glacial acetic acid, heat the mixture on a steam bath for 2 hours, cool to room temperature, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Each mL of 0.1 N perchloric acid is equivalent to 2.299 mg of Na.
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Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
1-301-816-8251
(SM32010) Monographs - Small Molecules 3
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 2501