U.S. PHARMACOPEIA

Search USP29  
Neomycin Sulfate and Triamcinolone Acetonide Ophthalmic Ointment
» Neomycin Sulfate and Triamcinolone Acetonide Ophthalmic Ointment 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 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 201BNP.
B: Place 2 g of Ophthalmic Ointment in a conical flask, add 5.0 mL of chloroform, and shake for 10 minutes. Add 15 mL of alcohol, and shake for an additional 10 minutes. Filter the solution into a centrifuge tube, and evaporate the filtrate to dryness. Dissolve the residue in alcohol to obtain a solution containing about 250 µg of triamcinolone acetonide per mL. Proceed as directed in the Identification test under Triamcinolone Acetonide Cream, beginning with “Apply 10 µL of this solution”: the specified result is observed.
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 triamcinolone acetonide— Proceed with Ophthalmic Ointment as directed in the Assay under Triamcinolone Acetonide Cream, except to read “Ophthalmic Ointment” in place of “Cream” throughout.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1515
Pharmacopeial Forum : Volume No. 28(4) Page 1166
Phone Number : 1-301-816-8223