Bleomycin for Injection
» Bleomycin for Injection contains an amount of Bleomycin Sulfate equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of bleomycin.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 10.0 USP Endotoxin Units per Bleomycin Unit.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, the entire contents of each container being used.
Water, Method Ic 921: not more than 6.0%. Prepare the specimen for test as follows. Use a dry syringe to inject 4 mL of 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 8 mL of the anhydrous methanol. Determine the weights of the empty containers, and calculate the percentage of water.
Other requirements It meets the requirements for pH, Copper, and Content of bleomycins under Bleomycin Sulfate. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
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. 16 to obtain a solution having a convenient concentration.
Procedure Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately measured volume of Assay preparation diluted quantitatively and stepwise with Buffer No. 16 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 2377Pharmacopeial Forum: Volume No. 34(5) Page 1150