Packaging and storage— Preserve in well-closed containers.

Identification— Asolution of Tablets responds to the tests for Sodium á191ñand for Bicarbonate á191ñ.

Disintegration á701ñ: 30minutes,simulated gastric fluid TSbeing substituted for water in the test.

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 2g of sodium bicarbonate,dissolve in 100mLof water,add methyl red TS,and titrate with 1Nhydrochloric 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 mLof 1Nhydrochloric acid is equivalent to 84.01mg of NaHCO3.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 1778

Phone Number:1-301-816-8251