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 90.0 percent and not more than 110.0 percent 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 50 mL of the Assay preparation prepared as directed in the Assay on a steam bath just to dryness, dissolve the residue in 1 mL of chloroform, and proceed as directed under Thin-layer Chromatographic Identification Test 201.
Sterility 71: meets the requirements.
pH 791: between 6.0 and 8.0.
Assay Proceed as directed in the Assay under Hydrocortisone Acetate Injectable Suspension, except to read Ophthalmic Suspension in place of Injectable Suspension.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2579Pharmacopeial Forum: Volume No. 27(6) Page 3302