Triamcinolone Hexacetonide

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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C₃₀H₄₁FO₇            532.64

Pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-9-uoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-;

9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate) CAS RN: 5611-51-8; UNII: I7GT1U99Y9.

1 DEFINITION

Triamcinolone Hexacetonide contains NLT 97.0% and NMT 102.0% of C₃₀H₄₁FO₇, calculated on the dried basis.

2 IDENTIFICATION

Change to read:

SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{(CN 1-MAY-2020)}

3 ASSAY

PROCEDURE

Mobile phase: Methanol and water (3:1)

System suitability solution: 0.4 mg/mL each of USP Triamcinolone Acetonide RS and USP Triamcinolone Hexacetonide RS in methanol

Standard solution: 0.4 mg/mL of USP Triamcinolone Hexacetonide RS in methanol

Sample solution: 0.4 mg/mL of Triamcinolone Hexacetonide in methanol

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm x 25-cm; packing L1

Flow rate: 2 mL/min

Injection size: 10 µL

System suitability

Sample: System suitability solution

[NOTE-The relative retention times for triamcinolone acetonide and triamcinolone hexacetonide are 0.27 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 7.5 between triamcinolone acetonide and triamcinolone hexacetonide

Tailing factor: NMT 1.3 for triamcinolone hexacetonide

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₃₀H₄₁FO₇ in the portion of Triamcinolone Hexacetonide taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Triamcinolone Hexacetonide RS in the Standard solution (mg/mL)

C_u = concentration of Triamcinolone Hexacetonide in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–102.0% on the dried basis

4 IMPURITIES

Organic Impurities

Procedure: Limit of Triamcinolone Acetonide

Mobile phase, System suitability solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Standard solution: 0.004 mg/mL of USP Triamcinolone Acetonide RS in methanol

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of triamcinolone acetonide in the portion of Triamcinolone Hexacetonide taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of triamcinolone acetonide from the Sample solution

r_s = peak response of triamcinolone acetonide from the Standard solution

C_s = concentration of USP Triamcinolone Acetonide RS in the Standard solution (mg/mL)

C_u = concentration of Triamcinolone Hexacetonide in the Sample solution (mg/mL)

Acceptance criteria: NMT 1.0%

5 SPECIFIC TESTS

Optical Rotation, Specific Rotation〈781S〉

Sample solution: 10 mg/mL in chloroform

Acceptance criteria: +91° to +98°

Loss on Drying 〈731〉: Dry a sample in a vacuum at 60° for 4 h: it loses NMT 2.0% of its weight.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

USP Reference Standards 〈11〉

USP Triamcinolone Acetonide RS

USP Triamcinolone Hexacetonide RS