Rimexolone Ophthalmic Suspension
»Rimexolone Ophthalmic Suspension is a sterile suspension of Rimexolone in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent 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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Viscosity á911ñ: between 50and 350centipoises.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 6.0and 8.0.
Assay—
Mobile phase,Standard preparation,Chromatographic system— Proceed as directed in the Assayunder Rimexolone.
Assay preparation— Transfer an accurately weighed portion of Ophthalmic Suspension,equivalent to about 25mg of Rimexolone,to a 25-mLvolumetric flask,dilute with methanol to volume,and sonicate for 2minutes.Transfer 5.0mLof this suspension to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,mix,and filter.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in mg per mL,of USP Rimexolone RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1735
Phone Number:1-301-816-8143
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