Polymyxin B for Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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 as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution, 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.
USP Reference standards 〈11〉—
USP Polymyxin B Sulfate RS
Constituted solution—At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Specic Tests, Completeness and clarity of solutions.
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 Tests 〈71〉 —It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate Matter in Injections 〈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.
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 Labeling 〈7〉, Labels and Labeling for Injectable Products.
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 B.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 B.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 B.6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
