Sodium Bicarbonate Intravenous Infusion

Sodium Bicarbonate Injection

Sodium Bicarbonate Intravenous Infusion is a sterile solution of Sodium Bicarbonate in Water for Injections.

The intravenous infusion complies with the requirements stated under Parenteral Preparations and with the following requirements.

94.0 to 106.0% of the stated amount.

A. The residue on evaporation, when moistened with hydrochloric acid and introduced on a platinum wire into a flame, imparts a yellow colour to the flame.

B. Yields reaction A characteristic of sodium salts and the reactions characteristic of bicarbonates, Appendix VI.

Carry out the test for bacterial endotoxins, Appendix XIV C. The endotoxin limit concentration is less than 1.7 IU per mL of Sodium Bicarbonate Intravenous Infusion.

Titrate a volume containing 1 g of Sodium Bicarbonate with 0.5m hydrochloric acid VS using methyl orange solution as indicator. Each mL of 0.5m hydrochloric acid VS is equivalent to 42.00 mg of NaHCO₃.

Containers that have previously been subjected to heating in an autoclave should not be re-used to keep Sodium Bicarbonate Intravenous Infusion.

The strength is stated as the percentage w/v of Sodium Bicarbonate.

The label states (1) that containers containing visible particles must not be used; (2) the approximate concentrations, in millimoles per litre, of the sodium ions and the bicarbonate ions.

For a preparation containing 1.4% w/v of Sodium Bicarbonate the concentration of each ion is stated as 167 millimoles per litre.