Bleomycin for Injection
»Bleomycin for Injection contains an amount of Bleomycin Sulfate equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of bleomycin.
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.
Bacterial endotoxins á85ñ— It contains not more than 10.0USP Endotoxin Units per Bleomycin Unit.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,the entire contents of each container being used.
Water,Method Ic á921ñ: not more than 6.0%.Prepare the specimen for test as follows.Use a dry syringe to inject 4mLof anhydrous methanol through the stoppers of two tared containers,respectively,and shake to dissolve.Using the same syringe,aspirate the contents of the two containers,transfer to the titration vessel,and titrate.Perform a blank determination on 8mLof the anhydrous methanol.Determine the weights of the empty containers,and calculate the percentage of water.
Other requirements— It meets the requirements for Identificationtests,pH,Copper,and Content of bleomycinsunder Bleomycin Sulfate.It meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Assay preparation— Constitute Bleomycin for Injection as directed in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and quantitatively dilute with Buffer No.16to obtain a solution having a convenient concentration.
Procedure— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively and stepwise with Buffer No.16to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 272
Pharmacopeial Forum:Volume No.29(4)Page 1011
Phone Number:1-301-816-8335