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.
USP Reference standards 11
USP Hydrocortisone Acetate RS Click to View Structure
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.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3437
Pharmacopeial Forum: Volume No. 27(6) Page 3302