Neomycin Sulfate and Triamcinolone Acetonide Ophthalmic Ointment
»Neomycin Sulfate and Triamcinolone Acetonide Ophthalmic Ointment 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 triamcinolone acetonide (C24H31FO6).
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: Place 2g of Ophthalmic Ointment in a conical flask,add 5.0mLof chloroform,and shake for 10minutes.Add 15mLof alcohol,and shake for an additional 10minutes.Filter the solution into a centrifuge tube,and evaporate the filtrate to dryness.Dissolve the residue in alcohol to obtain a solution containing about 250µg of triamcinolone acetonide per mL.Proceed as directed in the Identificationtest under Triamcinolone Acetonide Cream,beginning with “Apply 10µLof this solution”:the specified result is observed.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder 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 triamcinolone acetonide— Proceed with Ophthalmic Ointment as directed in the Assayunder Triamcinolone Acetonide Cream,except to read “Ophthalmic Ointment”in place of “Cream”throughout.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1364
Pharmacopeial Forum:Volume No.28(4)Page 1166
Phone Number:1-301-816-8335