Sodium Bicarbonate Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Sodium Bicarbonate Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaHCO₃.

1 Packaging and storage

Preserve in well-closed containers.

2 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.

3 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.