(Ph. Eur. 11.6 update)
Action and use
Radio-opaque injection.
DEFINITION
Iodised Oil Fluid Injection is a sterile iodine addition product of the ethyl esters of the fatty acids obtained from poppy-seed oil.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of combined iodine
37.0 to 39.0% w/w.
CHARACTERISTICS
A straw-coloured or yellow, oily liquid.
Practically insoluble in water; soluble in chloroform, in ether and in petroleum spirit (boiling range, 40° to 60°).
IDENTIFICATION
Boil 0.05 mL with 2 mL of glacial acetic acid and 0.1 g of zinc powder for 2 minutes, add 5 mL of water, shake, decant from any undissolved zinc and add 1 mL of hydrogen peroxide solution (20 vol). Iodine vapour is evolved.
TESTS
Acidity
To 5 mL of chloroform add 5 mL of ethanol (96%) previously neutralised to phenolphthalein solution R1 with 0.1M ethanolic sodium hydroxide VS, add 5 g of the injection, shake and titrate with 0.1M ethanolic sodium hydroxide VS using phenolphthalein solution R1 as indicator. Not more than 1.0 mL is required to change the colour of the solution.
Weight per mL
1.28 to 1.30 g, Appendix V G.
Free iodine
Shake 1 g with 1 mL of starch mucilage and 1 mL of cadmium iodide solution. Any blue colour disappears on the addition of 0.4 mL of 0.01M sodium thiosulfate.
ASSAY
Boil 1 g with 10 mL of glacial acetic acid and 1 g of zinc powder under a reflux condenser for 1 hour. Add through the condenser 30 mL of hot water, filter through absorbent cotton, wash the flask with two 20 mL quantities of hot water and pass the washings through the filter. Cool the filtrate, add 25 mL of hydrochloric acid and 8 mL of potassium cyanide solution and titrate with 0.05M potassium iodate VS until the dark brown solution which is produced becomes light brown; add 5 mL of starch mucilage and continue the titration until the blue colour disappears. Each mL of 0.05M potassium iodate VS is equivalent to 12.69 mg of combined iodine.
STORAGE
Iodised Oil Fluid Injection should be kept in an atmosphere of carbon dioxide or nitrogen and protected from light.
