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STREPTOMYCIN SULFATE INJECTION

Category Antibacterial

      Streptomycin Sulfate Injection contains an amount of Streptomycin Sulfate equivalent to not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of C21H39N7O12.

Description Colourless to yellow solution.

Strength available 0.5 g (base) per ml.

Dose In combination with other antibacterials.

      Adults: Intramuscular, 1 g daily. Dosage should be reduced to 1 g two or three times a week as soon as clinically feasible. The maximum total dose should not exceed 4 g daily.

      Children: Intramuscular, 5 to 10 mg per kg of body weight every 6 hours, or 10 to 20 mg per kg of body weight every 12 hours. 

Contra-indication; Warning; Precaution See under Gentamicin Sulfate, p. 111.

Packaging and storage Streptomycin Sulfate Injection shall be kept in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light and stored at a temperature between 2º to 8º.

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

Identification

      A. Carry out the test as described in the “Thin-layer Chromatography” (Appendix 3.1), using a 7 per cent w/v solution of potassium dihydrogenphosphate as the mobile phase and the plate prepared in the following manner. Mix 300 mg of carbomer with 240 ml of water, allow to stand with moderate shaking for 1 hour, adjust to pH 7 by the gradual addition, with constant shaking, of 2 M sodium hydroxide and add 30 g of silica gel H. Spread a uniform layer of the resulting suspension 0.75 mm thick. Heat the plate at 110º for 1 hour, allow to cool and use immediately. Apply separately to the plate, 10 μl of each of the following solutions. For solution (A) dilute a suitable volume of the injection with sufficient water to produce a solution containing the equivalent of 0.08 per cent w/v of streptomycin. Solution (B) contains 0.1 per cent w/v of Streptomycin Sulfate RS in water. Solution (C) contains 0.1 per cent w/v of Streptomycin Sulfate RS, 0.1 per cent w/v of Neomycin Sulfate RS and 0.1 per cent w/v of Kanamycin Sulfate RS in water. After removal of the plate, allow it to dry in a current of warm air, spray with a mixture of equal volumes of a 0.2 per cent w/v solution of 1,3- naphthalenediol in ethanol and a 46 per cent w/v solution of sulfuric acid, and heat at 150º for 5 to 10 minutes: the principal spot in the chromatogram obtained from solution (A) corresponds to that in the chromatogram obtained from solution (B). The test is not valid unless the chromatogram obtained from solution (C) shows three clearly separated principal spots.

      B. Dilute 1 drop with 4 ml of water, add 1 ml of 1 M sodium hydroxide and heat in a water-bath for 4 minutes. Add a slight excess of hydrochloric acid and 2 drops of iron(III) chloride TS: a violet colour is produced.

pH 5.0 to 8.0 (Appendix 4.11).

Streptomycin B Not more than 3.0 per cent w/w. Carry out the test as described in the Streptomycin B under Streptomycin Sulfate, p. 149.

Test solution Dilute a volume of the injection containing the equivalent of 160 mg of the substance in Diluting solution.

      Any spot corresponding to streptomycin B in the chromatogram obtained from Test solution is not more intense than the spot in the chromatogram obtained from Standard solution.

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.25 Endotoxin Unit per mg of streptomycin.

Assay Dilute an accurately measured volume of Streptomycin Sulfate Injection, equivalent to about 330 mg of streptomycin, to 100 ml with water, and proceed as directed under the microbiological assay of Streptomycin Sulfate according to the “Microbiological Assay of Antibiotics” (Appendix 6.10).

Other requirements Complies with the requirements described under “Parenteral Preparations” (Appendix 1.16).

MONOGRAPHS • STREPTOMYCIN SULFATE INJECTION
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หมายเหตุ / Note : TP II 2011 PAGE 151 - 152