Packaging and storage
Preserve in well-closed containers.
Identification
Powder a number of Tablets, equivalent to about 25 mg of triamcinolone, and digest with 25 mL of acetone for 15 minutes. Filter through a fine-porosity, sintered-glass filtering funnel into about 100 mL of solvent hexane, swirl the liquid, and allow to stand for 30 minutes. Collect the crystals that form, wash the crystals with three 10-mL portions of water followed by 2 mL of acetone, and dry at 60
for 1 hour: the dried crystals so obtained respond to
Identification test
A under
Triamcinolone.
Dissolution 711
Medium:
0.01 N hydrochloric acid; 900 mL.
Apparatus 1:
100 rpm.
Time:
45 minutes.
Procedure
Determine the amount of C
21H
27FO
6 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 238 nm 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 RS in the same
Medium.
Tolerances
Not less than 75% (Q) of the labeled amount of C21H27FO6 is dissolved in 45 minutes.
Assay
Mobile phase
, Internal standard solution, Standard preparation, and Chromatographic systemPrepare as directed in the Assay under Triamcinolone.
Assay preparation
Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 10 mg of triamcinolone, to a suitable container. Add 50.0 mL of Internal standard solution, and shake vigorously by mechanical means for 10 minutes. Centrifuge for 10 minutes or until a clear supernatant is obtained.
Procedure
Proceed as directed for
Procedure in the
Assay under
Triamcinolone. The relative retention times are about 1.0 for triamcinolone and 1.9 for hydrocortisone. Calculate the quantity, in mg, of C
21H
27FO
6 in the portion of Tablets taken by the formula:
50C(RU / RS),
in which the terms are as defined therein.