Dronabinol
6H-Dibenzo[b,d]pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-. (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol ![]() ![]() ![]() » Dronabinol is D9-tetrahydrocannabinol. It contains not less than 95.0 percent of C21H30O2.
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Packaging and storage—
Preserve in tight, light-resistant glass containers in inert atmosphere. ![]() ![]()
Identification—
A:
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B:
Visualizing agent—Transfer about 100 mg of Fast Blue B salt to a suitable flask containing about 100 mL of methanol, stir for about 5 minutes, and allow to settle. Decant the clear liquid into the sprayer reservoir. [note—Prepare fresh daily.]
Identification solution—
Use the Standard preparation, prepared as directed in the Assay.
Test solution—
Use the Assay preparation.
Procedure—
Apply separately 10 µL each of the Identification solution and the Test solution to a suitable thin-layer chromatographic plate (see Chromatography
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Related compounds—
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Mobile phase, System suitability solution, and Standard preparation
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Standard solution—
Dilute an accurately measured volume of the Standard preparation quantitatively, and stepwise if necessary, with dehydrated alcohol to obtain a solution having a known concentration of about 0.004 mg per mL.
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Test solution—
Use the Assay preparation.
![]() (2H)/h
in which H is the measured height of the peak, and h is the amplitude of the average measured baseline noise; the signal-to-noise ratio is not less than 10.![]()
Procedure—
Separately inject equal volumes
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Table 1
Calculate the percentage of each impurity in the portion of Dronabinol taken by the formula:
100(1/F)(CV/W)(rU / rS)
in which F is the relative response factor for each impurity (see Table 1); C is the concentration, in mg per mL, of D9-tetrahydrocannabinol in the Standard solution; V is the volume, in mL, of the Test solution; W is the weight, in mg, of Dronabinol taken to prepare the Test solution; rU is the peak area response of each impurity in the Test solution; and rS is the peak area response of D9-tetrahydrocannabinol in the Standard solution. In addition to not exceeding the limits in Table 1, not more than 5.0% of total impurities is found.
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Assay—
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Mobile phase—
Prepare a filtered and degassed mixture of methanol, water, tetrahydrofuran, and acetonitrile (45:25:20:10), making adjustments, if necessary (see System Suitability under Chromatography
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System suitability solution—
Transfer accurately measured volumes of USP D9-Tetrahydrocannabinol RS and USP Exo-tetrahydrocannabinol RS to a suitable volumetric flask, and dilute with dehydrated alcohol to prepare a solution that contains about 200 µg of D9-tetrahydrocannabinol and about 10 µg of exo-tetrahydrocannabinol per mL.
Standard preparation—
Quantitatively dilute an accurately measured volume of USP D9-Tetrahydrocannabinol RS with dehydrated alcohol to obtain a solution having a known concentration of about 0.2 mg per mL.
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Assay preparation—
Transfer about 20 mg of Dronabinol, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with dehydrated alcohol to volume, and mix.
Chromatographic system (see Chromatography
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Procedure—
Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for all of the peaks. Calculate the quantity, in mg, of C21H30O2 in the portion of Dronabinol taken by the formula:
CV(rU / rS)
in which C is the concentration, in mg per mL, of D9-tetrahydrocannabinol in the Standard preparation; V is the volume, in mL, of the Assay preparation; and rU and rS are the D9-tetrahydrocannabinol peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
USP32–NF27 Page 2217
Pharmacopeial Forum: Volume No. 34(1) Page 90
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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