Amcinonide Ointment
»Amcinonide Ointment is Amcinonide in a suitable ointment base.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of amcinonide (C28H35FO7).
Packaging and storage— Preserve in tight containers.
Identification— It meets the requirements for the Identificationtest under Amcinonide Cream.
Microbial limits á61ñ It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
Assay—
Solution A,Solution B,Mobile phase,System suitability solution,Standard preparation,and Chromatographic system Proceed as directed in the Assayunder Amcinonide,except to use a 240-nm detector.
Assay preparation— Dissolve an accurately weighed quantity of Ointment in a suitable volume of a mixture of acetonitrile and chloroform (4:1)by heating in a hot water bath,cooling,and adjusting quantitatively with the same solvent mixture to obtain a solution having a concentration of about 0.2mg of amcinonide per mL.Cool to room temperature,dilute with acetonitrile to volume,and filter.Transfer 5mLof this solution to a 50-mLvolumetric flask,dilute with Solution Bto volume,and mix.
Procedure— Separately inject equal volumes (about 10µL)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 amcinonide (C28H35FO7)in the portion of Ointment taken by the formula:
500C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Amcinonide RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 114
Phone Number:1-301-816-8139