Bleomycin for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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 as described in Packaging and Storage Requirements (659), Injection Packaging. Packaging for constitution.

USP REFERENCE STANDARDS (11)

USP Bleomycin Sulfate RS

Constituted solution-At the time of use, it meets the requirements for Injections and Implanted Drug Products (1), Specific Tests, Completeness

and clarity of solutions.

1 Identification

Change to read:

A: Spectroscopic Identification Tests (197), Infrared Spectroscopy: 197K (CN 1-May-2020).

B: It responds to the tests for Sulfate (191),

BACTERIAL ENDOTOXINS TEST (85) -It contains not more than 10.0 USP Endotoxin Units per Bleomycin Unit.

STERILITY TESTS (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 DETERMINATION, 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 (7). Labels and Labeling for Injectable Products.

2 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 B. 16 to obtain a solution having a convenient concentration.

Procedure-Proceed as directed under Antibiotics-Microbial Assays (81), using an accurately measured volume of Assay preparation diluted quantitatively and stepwise with Buffer B. 16 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.