Bacitracin Ophthalmic Ointment
» Bacitracin Ophthalmic Ointment is a sterile preparation of Bacitracin in an anhydrous ointment base. It contains not less than 90.0 percent and not more than 140.0 percent of the labeled amount of bacitracin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Sterility 71: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Metal particles 751: It meets the requirements.
Assay— Proceed with Ophthalmic Ointment as directed in the Assay under Bacitracin Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1622
Pharmacopeial Forum: Volume No. 28(4) Page 1070