Bacitracin Ophthalmic Ointment
»Bacitracin Ophthalmic Ointment is a sterile preparation of Bacitracin in an anhydrous ointment base.It contains not less than 90.0percent and not more than 140.0percent of the labeled amount of bacitracin.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Sterility á71ñ: meets the requirements.
Water,Method Iá921ñ: not more than 0.5%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Metal particles á751ñ: It meets the requirements.
Assay— Proceed with Ophthalmic Ointment as directed in the Assayunder Bacitracin Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 214
Pharmacopeial Forum:Volume No.28(4)Page 1070
Phone Number:1-301-816-8335
Return