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Category Antibacterial.

      Tobramycin Sulfate contains the equivalent of not less than 634 μg and not more than 739 μg of C₁₈H₃₇N₅O₉ per mg.

Description White to off-white powder; odourless.

Solubility Soluble in water.

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

Packaging and storage Tobramycin Sulfate shall be kept in tightly closed containers.

Labelling The label on the container states (1) the number of μg of activity per mg; (2) storage condition; (3) parenteral grade.

Identification

      A. Complies with the tests for Identification A, B and C described under Tobramycin, p. 160.

      B. It yields the reactions characteristic of sulfates (Appendix 5.1).

pH 6.0 to 8.0, in a 4.0 per cent w/v solution (Appendix 4.11).

Water Not more than 2.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

Heavy metals Not more than 30 ppm (Method II, Appendix 5.2). Use 0.67 g; for the Standard Preparation, use lead standard solution (1 ppm Pb).

Sulfated ash Not more than 1.0 per cent w/w, the charred residue being moistened with 2 ml of nitric acid and 5 drops of sulfuric acid (Appendix 5.3).

Chromatographic purity Not more than 1.0 per cent. Complies with the test described under Tobramycin, p. 160.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Mobile phase, 2,4-Dinitrofluorobenzene reagent, Tris(hydroxymethyl)aminomethane reagent, Standard preparation, Derivatization procedure, Resolution solution, Chromatographic system, and Procedure Proceed as directed in the Assay under Tobramycin, p. 161.

      Assay preparation Transfer an accurately weighed quantity of Tobramycin Sulfate, containing about 50 mg of tobramycin, to a 250-ml volumetric flask, dissolve in and dilute with water to volume, and mix.

      Calculation Calculate the content of C₁₈H₃₇N₅O₉ in the Tobramycin Sulfate taken, using the declared content of C₁₈H₃₇N₅O₉ in Tobramycin RS. 

Other requirements Tobramycin Sulfate intended for parenteral administration complies with the following additional requirements.

      Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 2.00 Endotoxin Units per mg of tobramycin.

      Sterility Complies with the “Sterility Test” (Method I, Appendix 10.1).