Carboxymethylcellulose Sodium Tablets
»Carboxymethylcellulose Sodium Tablets contain an amount of sodium (Na)equivalent to not less than 6.5percent and not more than 9.5percent of the labeled amount of carboxymethylcellulose sodium.
Packaging and storage— Preserve in tight containers.
Identification— Digest a quantity of powdered Tablets,equivalent to about 1g of carboxymethylcellulose sodium,with 50mLof water until solution is virtually complete,and filter:the filtrate responds to the following tests.
A: To about 30mLof the solution add 3mLof 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 Identificationtest Aresponds to the tests for Sodium á191ñ.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 500mg of carboxymethylcellulose sodium,add 80mLof glacial acetic acid,heat the mixture on a steam bath for 2hours,cool to room temperature,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Each mLof 0.1Nperchloric acid is equivalent to 2.299mg of Na.
Auxiliary Information— Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 359
Phone Number:1-301-816-8323