Streptomycin Injection
»Streptomycin Injection contains an amount of Streptomycin Sulfate equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of streptomycin (C21H39N7O12).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Bacterial endotoxins á85ñ— It contains not more than 0.25USP Endotoxin Unit per mg of streptomycin.
pHá791ñ: between 5.0and 8.0.
Other requirements— It responds to Identificationtest Aand meets the requirements for Sterilityunder Streptomycin for Injection.It meets also the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,System suitability solution,andChromatographic system— Proceed as directed in the Assayunder Streptomycin Sulfate.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 500mg of streptomycin,to a 500-mLvolumetric flask,dilute with water to volume,and mix.Transfer 5.0mLof this solution to a 200-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Streptomycin Sulfate.Calculate the quantity,in mg,of streptomycin (C21H39N7O12)in each mLof the Injection taken by the formula:
20(CP/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken to prepare the Assay preparation;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1805
Pharmacopeial Forum:Volume No.28(1)Page 86
Phone Number:1-301-816-8335