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GENTAMICIN SULFATE OINTMENT

Category Antibacterial.

      Gentamicin Sulfate Ointment contains 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 0.1 per cent w/w (base).

Dose Topical, to the skin, three or four times a day.

Warning See under Gentamicin Sulfate Cream, p. 113.

Packaging and storage Gentamicin Sulfate Ointment 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 Complies with the test for Identification described under Gentamicin Sulfate Cream, p. 113.

Water Not more than 1.0 per cent w/w, 20 ml of a mixture of 7 volumes of toluene and 3 volumes of methanol used in place of methanol in the titration vessel (Karl Fischer Method, Appendix 4.12).

Assay Carry out the Assay described under Gentamicin Sulfate Cream, p. 113.

Other requirements Comply with the requirements described under “Topical Semi-solid Preparations” (Appendix 1.16).

 

MONOGRAPHS • GENTAMICIN SULFATE OINTMENT
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หมายเหตุ / Note : TP II 2011 PAGE 115