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.
USP Reference standards 11
USP Bacitracin Zinc RS
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
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USP35NF30 Page 2296
Pharmacopeial Forum: Volume No. 28(4) Page 1070
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