Ammonium Chloride Delayed-Release Tablets
» Ammonium Chloride Delayed-Release Tablets contain not less than 94.0 percent and not more than 106.0 percent of the labeled amount of NH4Cl. Ammonium Chloride Delayed-Release Tablets are enteric-coated.
Packaging and storage— Preserve in tight containers.
Identification— A filtered solution of finely powdered Tablets, equivalent to ammonium chloride solution (1 in 10), responds to the tests for Ammonium 191 and for Chloride 191.
Disintegration 701: 2 hours, determined as directed for Enteric-Coated Tablets.
Limit of thiocyanate— Powder and dissolve in water a sufficient number of Tablets to make about 25 mL of ammonium chloride solution (1 in 10), and filter. Acidify 10 mL of the solution with hydrochloric acid, and add a few drops of ferric chloride TS: no reddish orange color is produced.
Assay— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 200 mg of ammonium chloride, to a 500-mL Kjeldahl flask, and add 200 mL of water and 50 mL of sodium hydroxide solution (2 in 5). Immediately connect the flask by means of a distillation trap to a well-cooled condenser, the delivery tube of which dips into 40 mL of boric acid solution (1 in 25) contained in a suitable receiver. Heat to boiling, and distill about 200 mL. Cool the liquid in the receiver, if necessary, then add methyl red TS, and titrate with 0.1 N sulfuric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sulfuric acid is equivalent to 5.349 mg of NH4Cl.
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Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
(SM32010) Monographs - Small Molecules 3
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 2189