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.
') + '&img=../../images/v35300/cas-3810-74-0.gif',600,500);)
Identification—
Iron reagent—
Dissolve 5 g of ferric chloride in 50 mL of 0.1 N hydrochloric acid. Transfer 2.5 mL of this stock solution to a 100-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Prepare the Iron reagent at the time of use.
Procedure—
Dissolve the specimen in water, and dilute with water to obtain a solution containing about 1 mg of streptomycin per mL. To 5 mL of this solution add 2.0 mL of 1 N sodium hydroxide, and heat in a water bath for 10 minutes. Cool in ice water for 3 minutes, then add 2.0 mL of 1.2 N hydrochloric acid, and mix. Add 5 mL of Iron reagent, and mix: a violet color is produced.
Bacterial endotoxins 
85
—
It contains not more than 0.25 USP Endotoxin Unit per mg of streptomycin.
85—
It contains not more than 0.25 USP Endotoxin Unit per mg of streptomycin.
pH 791:
between 5.0 and 8.0.
791:
between 5.0 and 8.0.
Other requirements—
It meets the requirements for Sterility under Streptomycin for Injection. It meets also the requirements under Injections 1.
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.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4690
Pharmacopeial Forum: Volume No. 34(5) Page 1193