Packaging and storage
Preserve in
Containers for Sterile Solids as described under
Injections 1.
Constituted solution
At the time of use, it meets the requirements for
Constituted Solutions under
Injections 1.
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.
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. 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.
Auxiliary Information
Staff Liaison :
Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29NF24 Page 296
Pharmacopeial Forum : Volume No. 29(4) Page 1011
Phone Number : 1-301-816-8223