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Streptomycin for Injection
» Streptomycin for 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).
Constituted solution
At the time of use, it meets the requirements for Constituted Solutions under Injections
Identification
A:
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 Iron reagent at the time of use. 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.
B:
It responds to the tests for Sulfate
Bacterial endotoxins
Sterility
pH
Loss on drying
Other requirements
It meets the requirements for Uniformity of Dosage Units
Assay
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system
Proceed as directed in the Assay under 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 0.025 mg 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 0.025 mg of streptomycin per mL.
Procedure
Proceed as directed in the Assay under 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 Calculate the quantity, in mg, of streptomycin (C21H39N7O12) withdrawn from the container, or in the portion of constituted solution taken by the formula: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 L is the labeled quantity, in mg, of streptomycin (C21H39N7O12) in the container, or in the volume of constituted solution taken; D is the concentration, in mg of streptomycin per mL, of Assay preparation 1 or 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
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3603
Pharmacopeial Forum: Volume No. 28(1) Page 86
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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