Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Sodium Bicarbonate Infusion is a sterile solution containing Sodium Bicarbonate. It is supplied as a ready-to-use solution.
The infusion complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of sodium bicarbonate, NaHCO3
94.0 to 106.0% of the stated amount.
IDENTIFICATION
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.
TESTS
Bacterial endotoxins
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 Infusion.
ASSAY
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.
STORAGE
Containers that have previously been subjected to heating in an autoclave should not be re-used to keep Sodium Bicarbonate Infusion.
LABELLING
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.
