Streptomycin for Injection
»Streptomycin for 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 Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification—
A: Dissolve 5g of ferric chloride in 50mLof 0.1Nhydrochloric acid.Transfer 2.5mLof this stock solution to a 100-mLvolumetric flask,dilute with 0.01Nhydrochloric acid to volume,and mix.Prepare Iron reagentat the time of use.Dissolve the specimen in water,and dilute with water to obtain a solution containing about 1mg of streptomycin per mL.To 5mLof this solution add 2.0mLof 1Nsodium hydroxide,and heat in a water bath for 10minutes.Cool in ice water for 3minutes,then add 2.0mLof 1.2Nhydrochloric acid,and mix.Add 5mLof Iron reagent,and mix:a violet color is produced.
B: It responds to the tests for Sulfate á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.25USP Endotoxin Unit per mg of streptomycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.5and 7.0,in a solution containing 200mg of streptomycin per mL.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 5.0%of its weight.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder Streptomycin Sulfate.
Assay preparation 1(where it is represented as being in a single-dose container)— Constitute Streptomycin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively,and stepwise if necessary,with water to obtain a solution containing about 0.025mg of streptomycin per mL.
Assay preparation 2(where the label states the quantity of streptomycin in a given volume of constituted solution)— Constitute Streptomycin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively,and stepwise if necessary,with water to obtain a solution containing about 0.025mg of streptomycin per mL.
Procedure— Proceed as directed in the Assayunder Streptomycin Sulfate.Calculate the quantity,in mg,of streptomycin (C21H39N7O12)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(CP/1000)(L/D)(rU/rS),
in which Lis the labeled quantity,in mg,of streptomycin (C21H39N7O12)in the container,or in the volume of constituted solution taken;Dis the concentration,in mg of streptomycin per mL,of Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container,or in the volume of constituted solution taken,respectively;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 1806
Pharmacopeial Forum:Volume No.28(1)Page 86
Phone Number:1-301-816-8335