Povidone-Iodine Eye Drops

NOTE: Povidone-Iodine Eye Drops are not currently licensed in the United Kingdom.

Antiseptic.

Povidone-Iodine Eye Drops are either a sterile solution of Iodinated Povidone in Purified Water or they are prepared by the interaction between Iodine and Povidone in Purified Water.

The eye drops comply with the requirements stated under Eye Preparations, the requirements stated under Unlicensed Medicines and with the following requirements.

95.0 to 105.0% of the stated amount.

A clear brown solution.

A. Dilute 1 mL to 10 mL with water and add 1 mL of the resulting solution to a mixture of 1 mL of starch mucilage and 9 mL of water. A deep blue colour is produced.

B. Transfer 20 mL to a small flask and cover the mouth of the flask with filter paper moistened with 0.05 mL of starch mucilage. No blue colour is produced on the paper within 60 seconds.

C. Dilute 4 mL to 10 mL with water and add, drop wise, 0.1m sodium thiosulfate until the colour of the iodine is just discharged. Reserve 5 mL of the resulting solution for test D. To 5 mL of the solution add 10 mL of 1m hydrochloric acid and 5 mL of a 7.0% w/v solution of potassium dichromate. A red precipitate is produced.

D. To 5 mL of the solution reserved in test C add 2 mL of ammonium cobaltothiocyanate solution previously acidified with 5m hydrochloric acid. A blue precipitate is produced.

pH, 3.5 to 6.5, Appendix V L.

Not more than 0.6% w/v, when determined by the following method. Dilute 10 mL of the solution being examined to 100 mL with water and add sodium metabisulfite until the colour of iodine has disappeared. Add 25 mL of 0.1m silver nitrate VS, 10 mL of nitric acid and 5 mL of ferric ammonium sulfate solution R2. Titrate with 0.1m ammonium thiocyanate VS. Repeat the procedure without the solution being examined. Each mL of 0.1m silver nitrate VS is equivalent to 12.69 mg of total iodine. Calculate the percentage content of total iodine and subtract the percentage content of available iodine, determined in the Assay, to obtain the percentage content of iodide.

To 5 mL add 10 mL of 0.1m hydrochloric acid and sufficient water to produce 30 mL. Titrate immediately with 0.01m sodium thiosulfate VS, determining the end point potentiometrically. Each mL of 0.01m sodium thiosulfate VS is equivalent to 1.269 mg of I.

Povidone-Iodine Eye Drops should be protected from light.

The strength is stated as the percentage w/v of Iodinated Povidone.