Neomycin Sulfate and Prednisolone Acetate Ophthalmic Ointment
»Neomycin Sulfate and Prednisolone Acetate Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate and Prednisolone Acetate.It contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin,and not less than 90.0percent and not more than 110.0percent of the labeled amount of prednisolone acetate (C23H30O6).
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification—
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test á201BNPñ.
B: The retention time of the major peak for prednisolone acetate in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,as obtained in the Assay for prednisolone acetate.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
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 neomycin— Proceed with Ophthalmic Ointment as directed in the Assayunder Neomycin Sulfate Ointment.
Assay for prednisolone acetate—
Mobile phase,Internal standard solution,Standard preparation,andChromatographic system— Prepare as directed in the Assay for prednisolone acetateunder Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension.
Assay preparation— Using Ophthalmic Ointment,proceed as directed for Assay preparationin the Assay for prednisolone acetateunder Neomycin Sulfate and Prednisolone Acetate Ointment.
Procedure— Proceed as directed for Procedurein the Assay for prednisolone acetateunder Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension.Calculate the quantity,in mg,of prednisolone acetate (C23H30O6)in the portion of Ophthalmic Ointment taken by the formula:
0.04C(RU/RS),
in which Cis the concentration,in µg per mL,of USP Prednisolone Acetate RSin the Standard preparation,and RUand RSare the peak response ratios of prednisolone acetate to betamethasone obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1362
Pharmacopeial Forum:Volume No.28(4)Page 1165
Phone Number:1-301-816-8335