Triamcinolone Diacetate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₂₅H₃₁FO₈             478.51

Pregna-1,4-diene-3,20-dione, 16,21-bis(acetyloxy)-9-uoro-11,17-dihydroxy-, (11β,16α)-.

9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,21-diacetate CAS RN: 67-78-7; UNII: A73MM2Q32P.

Triamcinolone Diacetate contains not less than 97.0 percent and not more than 103.0 percent of C₂₅H₃₁FO₈, calculated on the anhydrous basis.

Packaging and storage—Preserve in well-closed containers.

USP REFERENCE STANDARDS (11)-

USP Triamcinolone Diacetate RS

1 Identification

Change to read:

A:Spectroscopic Identification Tests (197), Infrared Spectroscopy: 197K _{(CN 1-May-2020)}.

Change to read:

B: Spectroscopic Identification Tests (197), Ultraviolet-Visible Spectroscopy: 1970 _{(CN 1-May-2020)}

Solution: 20 µg per mL.

Medium: dehydrated alcohol.

Absorptivities at 238 nm, calculated on the anhydrous basis, do not differ by more than 3.0%.

SPECIFIC ROTATION (7815): between +39° and +45°

Test solution: 5 mg per ml., in dimethylformamide.

WATER DETERMINATION, Method 1 (921): not more than 6.0%.

RESIDUE ON IGNITION (281): not more than 0.5%.

2 Assay

0.005 M Monobasic sodium phosphate solution-Dissolve monobasic sodium phosphate in water to obtain a solution containing 690 µg per mL.

Mobile phase-Prepare a mixture of 0.005 M Monobasic sodium phosphate solution, acetonitrile, and tetrahydrofuran (62:37:1), filter through a 0.45-µm solvent-resistant filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography (621)).

Standard preparation-Dissolve an accurately weighed quantity of USP Triamcinolone Diacetate RS in Mobile phase, and dilute quantitatively with Mobile phase to obtain a solution having a known concentration of about 40 µg per mL.

Assay preparation-Transfer about 50 mg of Triamcinolone Diacetate, accurately weighed, to a 50-mL volumetric flask, dissolve in Mobile phase, dilute with Mobile phase to volume, and mix. Pipet 2 mL of this solution into a second 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.

System suitability preparation-Dissolve suitable quantities of USP Triamcinolone Diacetate RS and Propylparaben in Mobile phase to obtain a solution containing about 40 µg per mL and 15 µg per mL, respectively.

Chromatographic system (see Chromatography (621))-The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm x 30-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the System suitability preparation, and record the peak responses as directed for Procedure: the relative retention times are 1.0 for triamcinolone diacetate and about 1.1 for propylparaben, the resolution, R, between the triamcinolone diacetate and propylparaben peaks is not less than 1.7, and the tailing factor, T, for the analyte peak is not more than 1.5. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation is not more than 2.0%.

Procedure-Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the area responses for the major peaks. Calculate the quantity, in mg, of C₂₅H₃₁FO₈ in the portion of Triamcinolone Diacetate taken 

1.25C(r_u /r_s )

in which C is the concentration, in µg per mL, of USP Triamcinolone Diacetate RS in the Standard preparation, and r_u and r_s are the peak area responses obtained from the Assay preparation and the Standard preparation, respectively.