Triamcinolone Acetonide 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 Acetonide Injectable Suspension is a sterile suspension of Triamcinolone Acetonide in a suitable aqueous medium. It contains NLT 90.0% and NMT 115.0% of the labeled amount of C₂₄H₃₁FO₆

2 IDENTIFICATION

Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K_{▲(CN 1-MAY-2020)}

Sample: Extract a volume of Injectable Suspension, equivalent to 50 mg of triamcinolone acetonide, with two 10-mL portions of peroxide-free ether, and discard the ether extracts. Filter with the aid of suction, wash with small portions of water, and dry the precipitate at 105° for 1 h.

Acceptance criteria: Meets the requirements

Change to read:

B. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 1970_{▲(CN 1-MAY-2020)}

Sample solution: 20 µg/mL in methanol, using the triamcinolone acetonide obtained from Identification test A

Acceptance criteria: Meets the requirements

3 ASSAY

PROCEDURE

Mobile phase: Acetonitrile and water (30:70)

Internal standard solution: 84 µg/mL of fluoxymesterone in methanol

Standard stock solution: 200 µg/mL of USP Triamcinolone

Standard solution: 80 µg/mL of USP Triamcinolone Acetonide RS from the Standard stock solution diluted with Internal standard solution

Sample stock solution: Dissolve a volume of freshly mixed Injectable Suspension in methanol to obtain a solution containing 200 µg/mL of triamcinolone acetonide.

Sample solution: 80 µg/mL of triamcinolone acetonide from the Sample stock solution diluted with Internal standard solution

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm x 30-cm; packing L1

Flow rate: 1.0 mL/min

Injection size: 15-25 µL

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 2.0 between triamcinolone acetonide and fluoxymesterone

Relative standard deviation: NMT 3.0% for five replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₂₄H₃₁FO₆ in the portion of Injectable Suspension taken:

                         Result = (R_U/R_S) × (C_S/C_U) × 100 

R_U = peak response ratio of the triamcinolone acetonide peak to the internal standard peak from the Sample solution

R_S = peak response ratio of the triamcinolone acetonide peak to the internal standard peak from the Standard solution

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

C_U = nominal concentration of triamcinolone acetonide in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-115.0%

4 PERFORMANCE TESTS

UNIFORMITY OF DOSAGE UNITS (905): Meets the requirements

5 SPECIFIC TESTS

BACTERIAL ENDOTOXING TEST (85): It contains NMT 4.4 USP Endotoxin Units/mg of triamcinolone acetonide.

PH (791): 5.0-7.5

INJECTIONS AND IMPLANTED DRUG PRODUCTS (1): Meets the requirements

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light. Store at controlled room temperature. Do not freeze,

USP REFERENCE STANDARDS (11)

USP Triamcinolone Acetonide RS