Sodium Bicarbonate Injection
» Sodium Bicarbonate Injection is a sterile solution of Sodium Bicarbonate in Water for Injection, the pH of which may be adjusted by means of added Carbon Dioxide. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaHCO3.
note—Do not use the Injection if it contains a precipitate.
Packaging and storage— Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I glass. Store at controlled room temperature.
Labeling— The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, 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 191 and for Bicarbonate 191.
Bacterial endotoxins 85 It contains not more than 5.0 USP Endotoxin Units per mEq.
pH 791: between 7.0 and 8.5.
Particulate matter 788: meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Assay— Measure accurately a volume of Injection, equivalent to about 3 g of sodium bicarbonate, 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 faint 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
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3566
Pharmacopeial Forum: Volume No. 31(5) Page 1401