Triamcinolone Acetonide Dental Paste
»Triamcinolone Acetonide Dental Paste is Triamcinolone Acetonide in a suitable emollient paste.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C24H31FO6.
Packaging and storage— Preserve in tight containers.
Identification— It responds to the Identificationtest under Triamcinolone Acetonide 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—
Mobile phase— Prepare as directed in the Assayunder Triamcinolone Acetonide Cream.
Internal standard solution and Standard preparation—Prepare as directed in the Assayunder Triamcinolone Acetonide Cream.
Assay preparation— Transfer an accurately weighed quantity of Dental Paste,equivalent to about 1.5mg of triamcinolone acetonide,to a screw-cap tube.Add 20.0mLof Internal standard solution,cap,and place in a sonic bath for 15to 20minutes.Place in a water bath at 70for 5minutes,then swirl for 1minute.Repeat the heating and swirling sequence once.Cool in an ice–methanol bath for 15minutes,then centrifuge for 10minutes at -5.Mix an accurately measured volume of the supernatant with an equal volume of Mobile phase.Place in an ice–methanol bath for 15minutes,then centrifuge for 15minutes.Draw off and discard the upper phase.Filter the lower phase to obtain a clear solution.
Procedure— Proceed as directed for Procedurein the Assayunder Triamcinolone Acetonide Cream.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1961
Phone Number:1-301-816-8139