Rimexolone Ophthalmic Suspension
» Rimexolone Ophthalmic Suspension is a sterile suspension of Rimexolone in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of rimexolone (C24H34O3). It may contain suitable stabilizers, buffers, and antimicrobial agents.
Packaging and storage— Preserve in well-closed containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Viscosity 911: between 50 and 350 centipoises.
Sterility 71: meets the requirements.
pH 791: between 6.0 and 8.0.
Mobile phase, Standard preparation, Chromatographic system— Proceed as directed in the Assay under Rimexolone.
Assay preparation— Transfer an accurately weighed portion of Ophthalmic Suspension, equivalent to about 25 mg of Rimexolone, to a 25-mL volumetric flask, dilute with methanol to volume, and sonicate for 2 minutes. Transfer 5.0 mL of this suspension to a 25-mL volumetric flask, dilute with Mobile phase to volume, mix, and filter.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of rimexolone (C24H34O3) in the portion of Ophthalmic Suspension taken by the formula:
125C(rU / rS)
in which C is the concentration, in mg per mL, of USP Rimexolone RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3510
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.