Polymyxin Bfor Injection
»Polymyxin Bfor Injection contains an amount of Polymyxin B Sulfate equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of polymyxin B.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,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 Solutionsunder Injections á1ñ.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Pyrogen— It meets the requirements of the Pyrogen Test á151ñ,the test dose being 1.0mLper kg of a solution in pyrogen-free saline TScontaining 20,000Polymyxin B Units per mL.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Residue on ignition á281ñ: not more than 5.0%,the charred residue being moistened with 2mLof nitric acid and 5drops of sulfuric acid.
Heavy metals,Method IIá231ñ: not more than 0.01%.
Other requirements— It meets the requirements forpHandLoss on drying underPolymyxin B Sulfate.It also meets the requirements forUniformity of Dosage Units á905ñand forLabeling underInjections á1ñ.
Assay—
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Polymyxin Bfor 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.6to obtain a solution containing a convenient number of Polymyxin B Units per mL.
Assay preparation 2 (where the label states the quantity of polymyxin Bin a given volume of constituted solution)—Constitute 1container of Polymyxin Bfor 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.6to obtain a solution containing a convenient number of Polymyxin B Units per mL.
Procedure— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively with Buffer No.6to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1577
Pharmacopeial Forum:Volume No.28(4)Page 1184
Phone Number:1-301-816-8335