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Streptomycin Injection
» Streptomycin Injection contains an amount of Streptomycin Sulfate equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of streptomycin (C21H39N7O12).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Bacterial endotoxins 85— It contains not more than 0.25 USP Endotoxin Unit per mg of streptomycin.
pH 791: between 5.0 and 8.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to Identification test A and meets the requirements for Sterility under Streptomycin for Injection. It meets also the requirements under Injections 1.
Assay—
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Streptomycin Sulfate.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 500 mg of streptomycin, to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 200-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed in the Assay under Streptomycin Sulfate. Calculate the quantity, in mg, of streptomycin (C21H39N7O12) in each mL of the Injection taken by the formula:
20(CP/V)(rU / rS),
in which V is the volume, in mL, of Injection taken to prepare the Assay preparation; and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 2009
Pharmacopeial Forum : Volume No. 28(1) Page 86
Phone Number : 1-301-816-8223