Trisodium Edetate Injection; Trisodium Edetate Intravenous Infusion
DEFINITION
Trisodium Edetate Infusion is a sterile solution conatining trisodium edetate. It is prepared immediately by diluting Trisodium Edetate Sterile Concentrate with a suitable diluent in accordance with the manufacturer’s instructions.
The infusion complies with the requirements stated under Parenteral Preparations and with the following requirements.
LABELLING
The strength is stated as the amount of trisodium edetate in a suitable dose-volume.
TRISODIUM EDETATE STERILE CONCENTRATE
DEFINITION
Trisodium Edetate Sterile Concentrate is a sterile solution in Water for Injections containing 20% w/v of trisodium edetate prepared by the interaction of Disodium Edetate and Sodium Hydroxide.
The concentrate complies with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements.
Content of trisodium edetate, C10H13N2Na3O8
19.0 to 21.0% w/v.
CHARACTERISTICS
A colourless solution.
IDENTIFICATION
A. Dilute 2.5 mL with 7.5 mL of water and add 0.5 mL of a 10% w/v solution of calcium chloride; make alkaline to litmus paper with 5M ammonia and add 5 mL of a 2.5% w/v solution of ammonium oxalate. No precipitate is produced.
B. Dilute 10 mL with 15 mL of water, 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; no precipitate is produced.
C. Evaporate to dryness and ignite. The residue yields the reactions characteristic of sodium salts, Appendix VI.
TESTS
Acidity or alkalinity
pH, 7.0 to 8.0, Appendix V L.
Bacterial endotoxins
Carry out the test for bacterial endotoxins, Appendix XIV C. If necessary dilute the infusion with water BET to give a solution containing 10 mg per mL (solution A). The endotoxin limit concentration of solution A is less than 1.4 IU per mL.
ASSAY
Dilute 10 mL to 100 mL with water and use this solution to titrate a mixture of 25 mL of 0.05M magnesium sulfate VS and 10 mL of ammonia buffer pH 10.9 using mordant black 11 mixed triturate as indicator. Each mL of 0.05M magnesium sulfate VS is equivalent to 17.91 mg of trisodium edetate, C10H13N2Na3O8.
STORAGE
Trisodium Edetate Sterile Concentrate should be kept in containers made from lead-free glass.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of trisodium edetate.
