U.S. PHARMACOPEIA

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Polymyxin B for Injection
» Polymyxin B for Injection contains an amount of Polymyxin B Sulfate equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of polymyxin B.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.
Labeling— Label it to indicate that where it is administered intramuscularly and/or intrathecally, it is to be given only to patients hospitalized so as to provide constant supervision by a physician.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Pyrogen— It meets the requirements of the Pyrogen Test 151, the test dose being 1.0 mL per kg of a solution in pyrogen-free saline TS containing 20,000 Polymyxin B Units per mL.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter 788: meets the requirements for small-volume injections.
Residue on ignition 281: not more than 5.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid.
Heavy metals, Method II 231: not more than 0.01%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for pH and Loss on drying under Polymyxin B Sulfate. It also meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Polymyxin B 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 with Buffer No. 6 to obtain a solution containing a convenient number of Polymyxin B Units per mL.
Assay preparation 2 (where the label states the quantity of polymyxin B in a given volume of constituted solution)—Constitute 1 container of Polymyxin B 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 with Buffer No. 6 to obtain a solution containing a convenient number of Polymyxin B Units per mL.
Procedure— Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of Assay preparation diluted quantitatively with Buffer No. 6 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
USP29–NF24 Page 1751
Pharmacopeial Forum : Volume No. 28(4) Page 1184
Phone Number : 1-301-816-8223