Packaging and storage—
Preserve in collapsible ophthalmic ointment tubes.
Labeling—
Label it to indicate the expiration date, which is not later than 2 years after date of manufacture.
Identification—
Place about 100 mg of Ointment in one eye of each of 3 rabbits, and examine the eyes 18 to 20 hours later: the average diameter of the pupils of the treated eyes is not less than 2 mm smaller than the average diameter of the pupils of the untreated eyes.
Irritation—
The conjunctivas of the eyes treated as directed in the
Identification test, as compared with those of the untreated eyes, after 1 hour, show not more than a slight reddening, which practically disappears in 4 hours.
Water, Method I 
921
—
Dissolve about 10 g, accurately weighed, in a mixture of 25 mL each of methanol and toluene. Not more than 0.03% is found.
Assay—
Solvent
,
Internal standard solution,
Standard preparation, and
Chromatographic system—Prepare as directed in the
Assay under
Isoflurophate.
Assay preparation—
Transfer about 3.5 g of Ophthalmic Ointment, accurately weighed, to a 50-mL centrifuge tube. Add 9 mL of Solvent and 1.0 mL of Internal standard solution, shake, and centrifuge. The bottom layer is the Assay preparation.
