Bacitracin for Injection
»Bacitracin for Injection has a potency of not less than 50Bacitracin Units per mg.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of bacitracin.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,and store in a cool place.
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.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per Bacitracin Unit.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Residue on ignition á281ñ: not more than 3.0%,the charred residue being moistened with 2mLof nitric acid and 5drops of sulfuric acid.
Heavy metals,Method IIá231ñ: not more than 0.003%.
Other requirements— It meets the requirements of the tests for pHand Loss on dryingunder Bacitracin.It meets the requirements under Injections á1ñand Uniformity of Dosage Units á905ñ.
Assay—
Assay preparation 1— Constitute 1container of Bacitracin for Injection as directed in the labeling.Using a suitable hypodermic needle and syringe,withdraw the contents of the container,and dilute quantitatively with Buffer No.1to obtain a solution containing about 100Bacitracin Units per mL.
Assay preparation 2 (where the label states the number of Bacitracin Units in a given volume of constituted solution)—Constitute 1container of Bacitracin for Injection as directed in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with Buffer No.1to obtain a solution containing about 100Bacitracin Units per mL.
Procedure— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparation.Add sufficient 0.01Nhydrochloric acid to the Assay preparationso that the amount of hydrochloric acid in the Test Dilutionwill be the same as in the median dose level of the Standard,and dilute quantitatively with Buffer No.1to obtain a Test Dilutionhaving a bacitracin 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 214
Pharmacopeial Forum:Volume No.28(4)Page 1069
Phone Number:1-301-816-8335