Dronabinol Capsules contain dronabinol in Sesame Oil. Dronabinol Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of dronabinol (C21H30O2).
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Mobile phase: Methanol, tetrahydrofuran, and water (71:5:24)
System suitability stock solution: 1.0 mg/mL of D8-tetrahydrocannabinol in methanol
System suitability solution: 0.5 mg/mL of USP D9-Tetrahydrocannabinol RS and 0.5 mg/mL of D8-tetrahydrocannabinol. Mix equal volumes of USP D9-Tetrahydrocannabinol RS and System suitability stock solution.
Standard solution: 0.2 mg/mL of USP D9-Tetrahydrocannabinol RS in dehydrated alcohol
Sample solution: Equivalent to 0.2 mg/mL of dronabinol, from Capsule contents (NLT 20) in dehydrated alcohol
Detector: UV 228 nm
Column: 4.6-mm × 15-cm; 3-µm packing L1
Guard column: 4.6-mm × 30-mm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 20 µL
Samples: System suitability solution and Standard solution [NoteThe relative retention times for D9-tetrahydrocannabinol and D8-tetrahydrocannabinol are about 1.0 and 1.14, respectively. ]
Resolution: NLT 2.0 between dronabinol and D8-tetrahydrocannabinol, System suitability solution
Tailing factor: NMT 2.0 of D9-tetrahydrocannabinol, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of C21H30O2 in the portion of Capsules taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• 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 Units 905: Meet the requirements
• Packaging and Storage: Preserve in well-closed, light-resistant containers, in a cool place.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2992Pharmacopeial Forum: Volume No. 35(3) Page 549