Category. Alkalinizing agent.

Storage. Sodium bicarbonate intravenous infusion should be kept in a sealed container. Containers that have previously been subjected to heating in an autoclave should not be re-used to keep Sodium bicarbonate intravenous infusion.

Labelling. The designation on the container of Sodium bicarbonate intravenous infusion should state:

• the strength as the percentage m/v of sodium bicarbonate, as well as the approximate concentrations, in millimoles per litre, of the sodium ions and the bicarbonate ions;
• that containers containing visible particles due to the possible formation of sodium carbonate precipitates must not be used.

Additional information. For a preparation containing 1% m/v of Sodium bicarbonate the concentration of each ion is about 119 millimoles per litre.

Requirements

Complies with the monograph for "Parenteral Preparations".

Definition. Sodium bicarbonate intravenous infusion is a sterile solution of Sodium hydrogen carbonate (Sodium bicarbonate) in Water for injections. It contains not less than 94.0% and not more than 106.0% of the amount of sodium bicarbonate (NaHCO₃) stated on the label.

The infusion is sterilized by a suitable method (see 5.8 Methods of sterilization).

Identity tests

A. The infusion yields reaction A described under 2.1 General identification tests, as characteristic of sodium.

B. Introduce 2 mL of the infusion into a test tube and add 3 mL of acetic acid (~120 g/l) TS. Close the tube immediately using a stopper fitted with a glass tube bent at two right angles. The solution effervesces evolving a colourless and odourless gas. Heat gently and collect the gas in 5 mL of barium hydroxide (15 g/l) TS. A white precipitate is produced which dissolves on addition of an excess of hydrochloric acid (~330 g/l) TS.

Bacterial endotoxins. Carry out the test as described under 3.4 Test for bacterial endotoxins; contains not more than 1.0 IU of endotoxin per mL.

Assay

Titrate a suitable volume of the infusion, accurately measured, containing about 1 g of Sodium bicarbonate with hydrochloric acid (0.5 mol/l) VS using methyl orange ethanol TS as indicator. Each mL of hydrochloric acid (0.5 mol/l) VS is equivalent to 42.00 mg of NaHCO₃.