Triamcinolone Hexacetonide Injectable Suspension

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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1 DEFINITION

Triamcinolone Hexacetonide Injectable Suspension is a sterile suspension of Triamcinolone Hexacetonide in a suitable aqueous medium. It contains NLT 90.0% and NMT 115.0% of the labeled amount of triamcinolone hexacetonide (C₃₀H₄₁FO₇)

2 IDENTIFICATION

Change to read:

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

Sample: Place a volume of Injectable Suspension, equivalent to 25 mg of triamcinolone hexacetonide, and 2 mL of water in a membrane filter of 0.20-µm pore size. Apply vacuum to the filter, wash the residue with two 5-mL portions of water, and air-dry the filter and the precipitate. Place the dried filter and precipitate in a small beaker with 5 mL of alcohol, and dissolve the precipitate. Decant the alcohol solution into a small beaker and evaporate with the aid of low heat and a current of air to dryness.

Acceptance criteria: Meets the requirements

3 ASSAY

PROCEDURE

Mobile phase: Methanol and water (3:1)

System suitability solution: 0.3 mg/mL of amcinonide and 0.4 mg/mL of USP Triamcinolone Hexacetonide RS in methanol

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

Sample solution: Using a "to contain" pipet, transfer a volume of Injectable Suspension, equivalent to 40 mg of triamcinolone hexacetonide, to a 100-mL volumetric flask. Rinse the pipet with methanol, collecting the rinse in the volumetric flask. Dilute with methanol to volume.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

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

Flow rate: 1.4 mL/min

Injection size: 10 µL

System suitability

Sample: System suitability solution

[NOTE-The relative retention times for amcinonide and triamcinolone hexacetonide are about 0.50 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 10 between amcinonide and triamcinolone hexacetonide

Tailing factor: NMT 1.2 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 Injectable Suspension taken:

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

r_u = peak response of triamcinolone hexacetonide from the Sample solution

r_s = peak response of triamcinolone hexacetonide from the Standard solution

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

C_u = nominal concentration of triamcinolone hexacetonide in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–115.0%

4 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉: Meets the requirements

5 IMPURITIES

Organic Impurities

Procedure: Limit of Triamcinolone Acetonide

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

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

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

System suitability

Sample: System suitability solution

Suitability requirements

Resolution: NLT 7.5 between triamcinolone acetonide and triamcinolone hexacetonide

Tailing factor: NMT 1.2 for triamcinolone hexacetonide

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of triamcinolone acetonide in the portion of Injectable Suspension 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 = nominal concentration of triamcinolone hexacetonide in the Sample solution (mg/mL)

Acceptance criteria: NMT 1.0%

6 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: It contains NMT 17.2 USP Endotoxin Units/mg of triamcinolone hexacetonide.

pH 〈791〉: 4.0–8.0

Injections and Implanted Drug Products 〈1〉: Meets the requirements

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Store at controlled room temperature.

Do not freeze.

USP Reference Standards 〈11〉

USP Triamcinolone Acetonide RS

USP Triamcinolone Hexacetonide RS