U.S. PHARMACOPEIA

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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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Ophthalmic Ointment as directed in the Assay under Bacitracin Ointment.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 234
Pharmacopeial Forum : Volume No. 28(4) Page 1070
Phone Number : 1-301-816-8223