Sodium Bicarbonate Tablets
» Sodium Bicarbonate Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaHCO3.
Packaging and storage— Preserve in well-closed containers.
Identification— A solution of Tablets responds to the tests for Sodium 191 and for Bicarbonate 191.
Disintegration 701: 30 minutes, simulated gastric fluid TS being substituted for water in the test.
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 2 g of sodium bicarbonate, dissolve in 100 mL of water, add methyl red TS, and titrate with 1 N hydrochloric acid VS. Add the acid slowly, with constant stirring, until the solution becomes faintly pink. Heat the solution to boiling, cool, and continue the titration until the pink color no longer fades after boiling. Each mL of 1 N hydrochloric acid is equivalent to 84.01 mg of NaHCO3.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3566