Triamcinolone Tablets
»Triamcinolone Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H27FO6.
Packaging and storage— Preserve in well-closed containers.
Identification— Powder a number of Tablets,equivalent to about 25mg of triamcinolone,and digest with 25mLof acetone for 15minutes.Filter through a fine-porosity,sintered-glass filtering funnel into about 100mLof solvent hexane,swirl the liquid,and allow to stand for 30minutes.Collect the crystals that form,wash the crystals with three 10-mLportions of water followed by 2mLof acetone,and dry at 60for 1hour:the dried crystals so obtained respond to Identificationtest Aunder Triamcinolone.
Dissolution á711ñ—
Medium: 0.01Nhydrochloric acid;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C21H27FO6dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 238nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,in comparison with a Standard solution having a known concentration of USP Triamcinolone RSin the same Medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C21H27FO6is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phase ,Internal standard solution,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Triamcinolone.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 10mg of triamcinolone,to a suitable container.Add 50.0mLof Internal standard solution,and shake vigorously by mechanical means for 10minutes.Centrifuge for 10minutes or until a clear supernatant is obtained.
Procedure— Proceed as directed for Procedurein the Assayunder Triamcinolone.The relative retention times are about 1.0for triamcinolone and 1.9for hydrocortisone.Calculate the quantity,in mg,of C21H27FO6in the portion of Tablets 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:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1958
Phone Number:1-301-816-8139