Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment
»Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment is a sterile ointment containing Oxytetracycline Hydrochloride and Polymyxin B Sulfate.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of oxytetracycline,and not less than 90.0percent and not more than 125.0percent of the labeled amount of polymyxin B.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Sterility á71ñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 1.0%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.
Assay for oxytetracycline— Proceed with Ophthalmic Ointment as directed in the Assay for oxytetracyclineunder Oxytetracycline Hydrochloride and Hydrocortisone Ointment.
Assay for polymyxin B— Proceed with Ophthalmic Ointment as directed in the Assay for polymyxin Bunder Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1453
Phone Number:1-301-816-8335
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