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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3602
Pharmacopeial Forum: Volume No. 34(5) Page 1193
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.