Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Used in Parenteral Nutrition Solutions.
DEFINITION
Sodium Acetate Sterile Concentrate is a sterile solution of Sodium Acetate Trihydrate in a suitable solvent.
The concentrate complies with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements. Where appropriate, the concentrate also complies with the requirements stated under Unlicensed Medicines.
Content of anhydrous sodium acetate, C2H3NaO2
95.0 to 105.0% of the stated amount.
Content of sodium, Na
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. Yields the reactions characteristic of sodium salts, Appendix VI.
B. Yields reaction A characteristic of acetates, Appendix VI.
TESTS
Alkalinity
pH of the concentrate, diluted if necessary to produce a solution containing the equivalent of 5% w/v of anhydrous sodium acetate, 7.5 to 9.0, Appendix V L.
ASSAY
For sodium acetate
Evaporate a volume of the concentrate containing the equivalent of 0.15 g of anhydrous sodium acetate to dryness; add 50 mL of anhydrous acetic acid and 10 mL of acetic anhydride and carry out Method I for non-aqueous titration, Appendix VIII A, using 1-naphtholbenzein solution as indicator. Each mL of 0.1M perchloric acid VS is equivalent to 8.20 mg of C2H3NaO2.
For Na
Prepare a suitable dilution in water and determine by atomic emission spectrophotometry, Appendix II D, measuring at 589 nm and using sodium standard solution (200 ppm Na), suitably diluted with water, for the standard solutions.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous sodium acetate and in terms of the concentration of sodium ions (Na+) in millimoles per mL.
