Isoflurophate Ophthalmic Ointment
»Isoflurophate Ophthalmic Ointment contains not less than 0.0225percent and not more than 0.0275percent 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 2years after date of manufacture.
Identification— Place about 100mg of Ointment in one eye of each of 3rabbits,and examine the eyes 18to 20hours later:the average diameter of the pupils of the treated eyes is not less than 2mm smaller than the average diameter of the pupils of the untreated eyes.
Irritation— The conjunctivas of the eyes treated as directed in the Identificationtest,as compared with those of the untreated eyes,after 1hour,show not more than a slight reddening,which practically disappears in 4hours.
Sterility á71ñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ— Dissolve about 10g,accurately weighed,in a mixture of 25mLeach 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 á751ñ.
Assay—
Solvent ,Internal standard solution,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Isoflurophate.
Assay preparation— Transfer about 3.5g of Ophthalmic Ointment,accurately weighed,to a 50-mLcentrifuge tube.Add 9mLof Solventand 1.0mLof Internal standard solution,shake,and centrifuge.The bottom layer is the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Isoflurophate.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1072
Phone Number:1-301-816-8330