Hydrocortisone Acetate Ophthalmic Suspension
»Hydrocortisone Acetate Ophthalmic Suspension is a sterile suspension of Hydrocortisone Acetate in an aqueous medium containing a suitable antimicrobial agent.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of total steroids,calculated as hydrocortisone acetate (C23H32O6).It may contain suitable buffers and suspending agents.
Packaging and storage— Preserve in tight containers.
Identification —Evaporate 50mLof theAssay preparation prepared as directed in theAssayon a steam bath just to dryness,dissolve the residue in 1mLof chloroform,and proceed as directed underThin-layer Chromatographic Identification Test á201ñ.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 6.0and 8.0.
Assay —Proceed as directed in theAssayunder Hydrocortisone Acetate Injectable Suspension,except to read Ophthalmic Suspension in place of Injectable Suspension.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 964
Pharmacopeial Forum:Volume No.27(6)Page 3302
Phone Number:1-301-816-8139
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