Triamcinolone Tablets
» Triamcinolone Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H27FO6.
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 C21H27FO6 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.
Uniformity of dosage units 905: meet the requirements.
Mobile phase , Internal standard solution, Standard preparation, and Chromatographic system—Prepare 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 C21H27FO6 in the portion of Tablets taken by the formula:
50C(RU / RS)
in which the terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3781
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.