Erythromycin Ophthalmic Ointment
» Erythromycin Ophthalmic Ointment is a sterile preparation of Erythromycin in a suitable ointment base. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C37H67NO13.
Packaging and storage Preserve in collapsible ophthalmic ointment tubes.
Identification Transfer a quantity of Ophthalmic Ointment, equivalent to about 5 mg of erythromycin, to a separator containing 50 mL of solvent hexane. Shake until dissolved. Extract with three separate 20-mL portions of methanol. Combine the methanol extracts in a beaker, and evaporate to dryness. Dissolve the residue in 2 mL of methanol (test solution). Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with Prepare a Standard solution of USP Erythromycin RS.
Sterility 71: It meets the requirements.
Minimum fill 755: meets the requirements.
Metal particles It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
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USP32NF27 Page 2286