Packaging and storage— Preserve in single-dose containers, of Type I glass.

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.

USP Reference standards 11— USP Endotoxin RS.

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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1973

Phone Number : 1-301-816-8251