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.
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—
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 Antibiotics—Microbial 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1621
Pharmacopeial Forum: Volume No. 28(4) Page 1069