Sodium Lactate Intravenous Infusion

Sodium Lactate Injection

Sodium Lactate Intravenous Infusion is a sterile solution containing 1.85% w/v of sodium lactate in Water for Injections, it is prepared from Sodium Lactate Solution (Ph Eur monograph 1151).

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

1.75 to 1.95% w/v.

A colourless solution.

A. When warmed with potassium permanganate, yields acetaldehyde.

B. 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.

C. Carry out reaction C characteristic of calcium salts, Appendix VI. No white precipitate is produced.

pH, 5.0 to 7.0, Appendix V L.

The endotoxin limit concentration is 0.25 IU per mL, Appendix XIV C.

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Dilute 1 volume of the infusion to 5 volumes with the mobile phase.

(2) 0.30% w/v of lithium lactate BPCRS in the mobile phase. 

(a) Use a stainless steel column (20 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable).

(b) Use isocratic elution and the mobile phase described below.

(c) Use a flow rate of 2 mL per minute.

(d) Use an ambient column temperature.

(e) Use a detection wavelength of 210 nm.

(f) Inject 20 µL of each solution.

10 volumes of a 2% v/v solution of octylamine in acetonitrile, the pH of the final mixture being adjusted to 7.0 with a 10% v/v solution of orthophosphoric acid and 90 volumes of water.

Calculate the content of C₃H₅NaO₃ in the infusion using the declared equivalent content of C₃H₅NaO₃ in lithium lactate BPCRS.

The label states (1) that solutions containing visible solid particles should not be used; (2) that the Intravenous Infusion is one-sixth molar and contains, in one litre, approximately 167 millimoles of sodium ions and of bicarbonate ions (as lactate).