Tobramycin Sulfate
(toe'' bra mye' sin sul' fate).
(C18H37N5O9)2·5H2SO4
1425.45
1425.45d-Streptamine, O-3-amino-3-deoxy-
-d-glucopyranosyl-(1®6)-O-[2,6-diamino-2,3,6-tridoexy--d-ribo-hexopyranosyl-(1®4)]-2-deoxy-, sulfate (2:5) (salt).
O-3-Amino-3-deoxy-
-d-glucopyranosyl-(1®4)-O-[2,6-diamino-2,3,6-trideoxy--d-ribo-hexopyranosyl-(1®6)]-2-deoxy-l-streptamine, sulfate (2:5) (salt)
[79645-27-5].» Tobramycin Sulfate has a potency of not less than 634 µg and not more than 739 µg of tobramycin (C18H37N5O9) per mg.
Packaging and storage—
Preserve in tight containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
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Identification—
A:
It responds to the Identification tests under Tobramycin.
B:
It responds to the tests for Sulfate 
191
.
191.
pH 791:
between 6.0 and 8.0, in a solution containing 40 mg per mL.
791:
between 6.0 and 8.0, in a solution containing 40 mg per mL.
Water, Method I 921:
not more than 2.0%.
921:
not more than 2.0%.
Other requirements—
It meets the requirements for Residue on ignition, Heavy metals, and Chromatographic purity under Tobramycin. Where the label states that Tobramycin Sulfate is sterile, it meets the requirements for Sterility Tests 71 and for Bacterial endotoxins under Tobramycin for Injection. Where the label states that Tobramycin Sulfate must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Tobramycin for Injection.
71 and for Bacterial endotoxins under Tobramycin for Injection. Where the label states that Tobramycin Sulfate must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Tobramycin for Injection.
Assay—
Mobile phase
, 2,4-Dinitrofluorobenzene reagent, Tris(hydroxymethyl)aminomethane reagent, Standard preparation, Derivatization procedure, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Tobramycin.
Assay preparation—
Transfer an accurately weighed quantity of Tobramycin Sulfate, equivalent to about 50 mg of tobramycin (C18H37N5O9), to a 250-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Procedure—
Proceed as directed for Procedure in the Assay under Tobramycin. Calculate the quantity, in µg, of tobramycin (C18H37N5O9) in each mg of the Tobramycin Sulfate taken by the formula:
250(CE / W)(rU / rS)
in which the terms are as defined therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4887