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Category Antibacterial (ophthalmic).

      Gentamicin Sulfate Eye Drops are a sterile, buffered solution of Gentamicin Sulfate with preservatives. They contain the equivalent of not less than 90.0 per cent and not more than 135.0 per cent of the labelled amount of gentamicin.

Strength available 0.3 per cent w/v (base).

Dose Topical, to the conjunctiva, 1 to 2 drops into the affected eye every 4 hours for mild to moderate infections or as often as once every hour for severe infections.

Warning See under Gentamicin Sulfate Cream, p. 113.

Packaging and storage Gentamicin Sulfate Eye Drops shall be stored at a temperature not exceeding 30º.

Labelling The label on the container states the quantity equivalent to the amount of gentamicin.

Identification Comply with the test for Identification C described under Gentamicin Sulfate, p. 113. Apply separately to the plate, (A) a volume of the eye drops equivalent to 30 μg of gentamicin and (B) 100 μg of Gentamicin Sulfate RS dissolved in a volume of water equal to the volume of the eye drops used.

pH 6.5 to 7.5 (Appendix 4.11).

Assay Proceed as directed under the microbiological assay of Gentamicin Sulfate according to the “Microbiological Assay of Antibiotics” (Appendix 6.10), using an accurately measured volume of Gentamicin Sulfate Eye Drops.

Other requirements Comply with the requirements described under “Eye Preparations” (Appendix 1.16).