Dronabinol Capsules

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

Dronabinol Capsules contain dronabinol in Sesame Oil. Dronabinol Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of dronabinol (C₂₁H₃₀O₂).

2 IDENTIFICATION

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay

3 ASSAY

PROCEDURE

Mobile phase: Methanol, tetrahydrofuran, and water (71:5:24)

System suitability stock solution: 1.0 mg/mL of Δ⁸-tetrahydrocannabinol in methanol

System suitability solution: 0.5 mg/mL of USP Δ⁹-Tetrahydrocannabinol RS and 0.5 mg/mL of Δ⁸-tetrahydrocannabinol. Mix equal volumes of USP Δ^{9 -}Tetrahydrocannabinol RS and System suitability stock solution.

Standard solution: 0.2 mg/mL of USP A-Tetrahydrocannabinol RS in dehydrated alcohol

Sample solution: Equivalent to 0.2 mg/ml of dronabinol, from Capsule contents (NLT 20) in dehydrated alcohol

Chromatographic system

(See Chromatography (621), System Suitability)

Mode: LC

Detector: UV 228 nm

Column: 4.6-mm 15-cm; 3-um packing L1

Guard column: 4.6-mm x 30-mm, 5-um packing L1

Flow rate: 1 mL/min

Injection size: 20 με

System suitability

FICIAL

Samples: System suitability solution and Standard solution [NOTE-The relative retention times for A-tetrahydrocannabinol and A. tetrahydrocannabinol are about 1.0 and 1.14, respectively.]

Suitability requirements

Resolution: NLT 2.0 between dronabinol and A-tetrahydrocannabinol, System suitability solution

Tailing factor: NMT 2.0 of 4-tetrahydrocannabinol, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C, H, O, in the portion of Capsules taken:

Result = (r_U/(r_S) × (C_S /C_U) × P x F x 100

r_U = peak response of dronabinol from the Sample solution

r_S = peak response of dronabinol from the Standard solution

C_S = concentration of USP Δ⁹-Tetrahydrocannabinol RS, in the Stardard solution (mg/ml)

C_U = nominal concentration of doxycycline in the Sample sulation (mg/ml)

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

DISSOLUTION (711)

Medium: Water; 500 ml.

Apparatus 2: 50 rpm

Time: 15 min

Analysis: Place 1 Capsule in each vessel, and allow the Capsule to sink to the bottom of the vessel before starting rotation of the blade.

Observe the Capsules, and record the time taken for each Capsule shell to rupture.

Tolerances: The requirements are met if all of the Capsules tested rupture in NMT 15 min. If 1 or 2 of the Capsules rupture in NLT 15 but NMT 30 min, repeat the test on 12 additional Capsules. NMT 2 of the total of 18 Capsules tested rupture in NLT 15 min but NMT 30 min.

UNIFORMITY OF DOSAGE UNITE (905): Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed, light-resistant containers, in a cool place.