Medium: water; 500 mL.

Apparatus 2: 50 rpm.

Time: 15 minutes.

Procedure— 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 not more than 15 minutes. If 1 or 2 of the Capsules rupture in more than 15 but not more than 30 minutes, repeat the test on 12 additional Capsules. Not more than 2 of the total of 18 Capsules tested rupture in more than 15 but not more than 30 minutes.

(Official January 1, 2007)

Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Dronabinol.

Assay preparation— Weigh and mix the contents of not less than 20 Capsules. Transfer an accurately weighed portion of the capsule contents, equivalent to about 20 mg of dronabinol, to a 100-mL volumetric flask, dilute with dehydrated alcohol to volume, and mix.

Procedure— Proceed as directed for Procedure in the Assay under Dronabinol. Calculate the quantity, in mg, of dronabinol (C21H30O2) in the portion of Capsules taken by the formula: in which C is the concentration, in mg per mL, of USP D9-Tetrahydrocannabinol RS in the Standard preparation, and rU and rS are the dronabinol peak responses obtained from the Assay preparation and the Standard preparation, respectively.