Erythromycin Ophthalmic Ointment
»Erythromycin Ophthalmic Ointment is a sterile preparation of Erythromycin in a suitable ointment base.It contains not less than 90.0percent and not more than 120.0percent 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 5mg of erythromycin,to a separator containing 50mLof solvent hexane.Shake until dissolved.Extract with three separate 20-mLportions of methanol.Combine the methanol extracts in a beaker,and evaporate to dryness.Dissolve the residue in 2mLof methanol (test solution).Proceed as directed in the Identificationtest under Erythromycin Delayed-Release Capsules,beginning with “Prepare a Standard solution of USP Erythromycin RS.”
Sterility á71ñ: It meets the requirements.
Minimum fill á755ñ: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.
Other requirements— It meets the requirements for Waterand Assayunder Erythromycin Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 761
Phone Number:1-301-816-8335