Bacitracin for Injection
» Bacitracin for Injection has a potency of not less than 50 Bacitracin Units per mg. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of bacitracin.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1, and store in a cool place.
USP Reference standards 11
USP Bacitracin Zinc RS
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 0.01 USP Endotoxin Unit per Bacitracin Unit.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Residue on ignition 281: not more than 3.0%, 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 0.003%.
Other requirements It meets the requirements of the tests for pH and Loss on drying under Bacitracin. It meets the requirements under Injections 1 and Uniformity of Dosage Units 905.
Assay preparation 1 Constitute 1 container 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. 1 to obtain a solution containing about 100 Bacitracin Units per mL.
Assay preparation 2 (where the label states the number of Bacitracin Units in a given volume of constituted solution)Constitute 1 container of Bacitracin for Injection as directed in the labeling. Quantitatively dilute an accurately measured volume of the constituted solution with Buffer No. 1 to obtain a solution containing about 100 Bacitracin Units per mL.
Procedure Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately measured volume of Assay preparation. Add sufficient 0.01 N hydrochloric acid to the Assay preparation so that the amount of hydrochloric acid in the Test Dilution will be the same as in the median dose level of the Standard, and dilute quantitatively with Buffer No. 1 to obtain a Test Dilution having a bacitracin concentration assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 2295Pharmacopeial Forum: Volume No. 28(4) Page 1069