Halcinonide Topical Solution
»Halcinonide Topical Solution is Halcinonide in a suitable aqueous vehicle.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C24H32ClFO5.
Packaging and storage— Preserve in well-closed containers.
Identification— It responds to the Identificationtest under Halcinonide Cream.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Assay—
Mobile phase— Mix approximately equal volumes of acetonitrile and water,adjusting the ratio of solvents as necessary to achieve acceptable chromatography.
Internal standard solution— Transfer 15mg of Progesterone to a 50-mLvolumetric flask.Dissolve in Mobile phase,dilute with Mobile phaseto volume,and mix.
Standard preparation— Transfer about 20mg of USP Halcinonide RS,accurately weighed,to a 100-mLvolumetric flask,dissolve in Mobile phase,dilute with Mobile phaseto volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,add 2.0mLof Internal standard solution,dilute with Mobile phaseto volume,and mix.
Assay preparation— Transfer an accurately measured quantity of Topical Solution,equivalent to about 1mg of halcinonide,to a 50-mLvolumetric flask,add 2.0mLof Internal standard solution,dilute with Mobile phaseto volume,and mix.
Chromatographic system and Procedure— Proceed as directed in the Assayunder Halcinonide Cream.Calculate the quantity,in mg,of C24H32ClFO5in the portion of Topical Solution taken by the formula:
50C(RU/RS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 937
Phone Number:1-301-816-8139