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 71
It meets the requirements when tested as directed for
Membrane Filtration under
Test for Sterility of the Product to be Examined.
Homogeneity
Transfer about 250 mg 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 20.0 g of it to a 400-mL beaker, add 100 mL of a 1 in 2 mixture of neutralized alcohol and water, agitate thoroughly, and gradually heat to boiling. Boil for 10 minutes. Add 1 mL of phenolphthalein TS and rapidly titrate, with vigorous agitation, with either 0.1 N sodium hydroxide VS (from a colorless alcohol-water layer to a sharp pink endpoint) or 0.1 N hydrochloric acid VS (from a pink alcohol-water layer to a colorless endpoint): not more than 0.40 mL of 0.1 N titrant is required.