Action and use
Used in the treatment of copper deficiency.
DEFINITION
Calcium Copperedetate Injection is a sterile suspension of Calcium Copperedetate, with suitable stabilising and dispersing agents, in an oil-in-water emulsion.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of copper, Cu
92.0 to 108.0% of the stated amount.
CHARACTERISTICS
Macroscopica:l A blue, opaque, viscous suspension.
Microscopical: When diluted with glycerol and examined microscopically, cubic crystals 10 to 30 μm in diameter are visible, but large plate-like crystals are absent.
IDENTIFICATION
Ignite 1 g and dissolve the residue by warming in 10 mL of a mixture of equal volumes of hydrochloric acid and water; filter if necessary. The solution complies with the following tests.
A. Neutralise 2 mL of the solution with 5M ammonia, and add 1 mL of 6M acetic acid and 2 mL of potassium iodide solution. A white precipitate is produced and iodine is liberated, colouring the supernatant liquid brown.
B. To 5 mL of the solution add 25 mL of a 10% v/v solution of mercaptoacetic acid and filter. Make the filtrate alkaline with 5M ammonia and add 5 mL of a 2.5% w/v solution of ammonium oxalate. A white precipitate is produced which is soluble in
hydrochloric acid but only sparingly soluble in 6M acetic acid.
ASSAY
Evaporate a quantity containing the equivalent of 0.13 g of copper to dryness, ignite at 600° to 700°, cool and heat the residue with 5 mL of a mixture of equal volumes of hydrochloric acid and water on a water bath for 15 minutes. Add 5 mL of water, filter and wash the residue with about 20 mL of water. Combine the filtrate and the washings, add 10 mL of bromine water, boil to remove the bromine, cool and add dilute sodium carbonate solution until a faint permanent precipitate is produced. Add 3 g of potassium iodide and 5 mL of 6M acetic acid and titrate the liberated iodine with 0.1M sodium thiosulfate VS, using starch mucilage as indicator, until only a faint blue colour remains; add 2 g of potassium thiocyanate and continue the titration until the blue colour disappears. Each mL of 0.1M sodium thiosulfate VS is equivalent to 6.354 mg of Cu.
LABELLING
The strength is stated as the equivalent amount of copper in a suitable dose-volume.
