Isoflurophate Ophthalmic Ointment
» Isoflurophate Ophthalmic Ointment contains not less than 0.0225 percent and not more than 0.0275 percent of C6H14FO3P, in a suitable anhydrous ointment base. It is sterile.
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.
Sterility 71: meets the requirements.
Minimum fill 755: meets the requirements.
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.
Metal particles It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Solvent , Internal standard solution, Standard preparation, and Chromatographic systemPrepare 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.
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USP35NF30 Page 3572