U.S. PHARMACOPEIA

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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 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and not less than 90.0 percent and not more than 110.0 percent 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 201BNP.
B: The retention time of the major peak for prednisolone acetate in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay for prednisolone acetate.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 1.0%, 20 mL of 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 751.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin— Proceed with Ophthalmic Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Assay for prednisolone acetate—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Prepare as directed in the Assay for prednisolone acetate under Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension.
Assay preparation— Using Ophthalmic Ointment, proceed as directed for Assay preparation in the Assay for prednisolone acetate under Neomycin Sulfate and Prednisolone Acetate Ointment.
Procedure— Proceed as directed for Procedure in the Assay for prednisolone acetate under 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 C is the concentration, in µg per mL, of USP Prednisolone Acetate RS in the Standard preparation, and RU and RS are the peak response ratios of prednisolone acetate to betamethasone obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1513
Pharmacopeial Forum : Volume No. 28(4) Page 1165
Phone Number : 1-301-816-8223