Packaging and storage— Preserve in suitable collapsible ophthalmic ointment tubes.

Appearance— Transfer a portion of it to a suitable test tube,and examine the sample in front of a light source:the sample should appear translucent.

Color— Examine the extruded ointment for color:it is colorless to light yellow.

Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

Homogeneity— Transfer about 250mg of it to a clean microscope slide and examine for separation:no oily or watery substances should be visibly separated from the ointment.Place a cover slip on the ointment and flatten until light readily passes through the sample.Examine for agglomeration:no solid particles are visible.

Acidity or alkalinity— Transfer 20.0g of it to a 400-mLbeaker,add 100mLof a 1in 2mixture of neutralized alcohol and water,agitate thoroughly,and gradually heat to boiling.Boil for 10minutes.Add 1mLof phenolphthalein TSand rapidly titrate,with vigorous agitation,with either 0.1Nsodium hydroxide VS(from a colorless alcohol-water layer to a sharp pink endpoint)or 0.1Nhydrochloric acid VS(from a pink alcohol-water layer to a colorless endpoint):not more than 0.40mLof 0.1Ntitrant is required.

Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 1421

Phone Number:1-301-816-8389