Tetracycline Hydrochloride Ophthalmic Ointment
»Tetracycline Hydrochloride Ophthalmic Ointment contains not less than 90.0percent and not more than 125.0percent of the labeled amount of C22H24N2O8·HCl.
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 0.5%,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— Proceed with Ophthalmic Ointment as directed in the Assayunder Tetracycline Hydrochloride Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1888
Phone Number:1-301-816-8335