Action and use
Chelating agent.
DEFINITION
Sodium Calcium Edetate Intravenous Infusion for Veterinary Use is a sterile solution of Sodium Calcium Edetate. It is prepared immediately before use by diluting Sodium Calcium Edetate Sterile Concentrate for Veterinary Use with a suitable diluent in accordance with the manufacturer’s instructions.
The intravenous infusion complies with the requirements stated under Parenteral Preparations and with the following requirement.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous sodium calcium edetate in a suitable dose-volume.
SODIUM CALCIUM EDETATE STERILE CONCENTRATE FOR VETERINARY USE
DEFINITION
Sodium Calcium Edetate Sterile Concentrate for Veterinary Use is a sterile solution of Sodium Calcium Edetate in Water for Injections containing the equivalent of 25.0% w/v of anhydrous sodium calcium edetate.
The concentrate complies with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements.
Content of anhydrous sodium calcium edetate, C10H12CaN2Na2O8
22.5 to 27.5% w/v.
CHARACTERISTICS
A colourless solution.
IDENTIFICATION
A. Dilute 2.5 mL with 7.5 mL of water, make alkaline to litmus paper with 5M ammonia and add 5 mL of a 2.5% w/v solution of ammonium oxalate. Not more than a trace of precipitate is produced.
B. To 10 mL add 2 mL of a 10% w/v solution of lead(II) nitrate, shake and add 5 mL of dilute potassium iodide solution; no yellow precipitate is produced. Make alkaline to litmus paper with 5M ammonia and add 5 mL of a 2.5% w/v solution of ammonium oxalate; a white precipitate is produced.
C. Evaporate to dryness and ignite. The residue yields the reactions characteristic of sodium salts and of calcium salts, Appendix VI.
TESTS
Acidity or alkalinity
pH, 6.5 to 8.0, Appendix V L.
Bacterial endotoxins
Carry out the test for bacterial endotoxins, Appendix XIV C. The endotoxin limit concentration is not more than 0.125 IU per mg of sodium calcium edetate.
ASSAY
To 2.5 mL add 90 mL of water, 7 g of hexamine and 5 mL of 2M hydrochloric acid and titrate with 0.05M lead nitrate VS using xylenol orange solution as indicator. Each mL of 0.05M lead nitrate VS is equivalent to 18.71 mg of C10H12CaN2Na2O8.
STORAGE
Sodium Calcium Edetate Sterile Concentrate for Veterinary Use should be kept in containers made from lead-free glass.
