Sodium Bicarbonate Injection
»Sodium Bicarbonate Injection is a sterile solution of Sodium Bicarbonate in Water for Injection,the pHof which may be adjusted by means of added Carbon Dioxide.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of NaHCO3.
NOTE—Do not use the Injection if it contains a precipitate.
Packaging and storage— Preserve in single-dose containers,of Type Iglass.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsmol per mL.
Identification— It responds to the tests for Sodium á191ñand for Bicarbonate á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 5.0USP Endotoxin Units per mEq.
pHá791ñ: between 7.0and 8.5.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Measure accurately a volume of Injection,equivalent to about 3g of sodium bicarbonate,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 faint pink color no longer fades after boiling.Each mLof 1Nhydrochloric acid is equivalent to 84.01mg of NaHCO3.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1778
Phone Number:1-301-816-8251
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