Packaging and storage—
Preserve in well-closed,light-resistant containers,in a cool place.
Identification—
The retention time of the major peak in the chromatogram of the
Assay preparationcorresponds to that in the chromatogram of the
Standard preparationas obtained in the
Assay.
Dissolution á711ñ—
Medium:
water;500mL.
Apparatus 2:
50rpm.
Time:
15minutes.
Procedure—
Place 1Capsule 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 15minutes.If 1or 2of the Capsules rupture in more than 15but not more than 30minutes,repeat the test on 12additional Capsules.Not more than 2of the total of 18Capsules tested rupture in more than 15but not more than 30minutes.
Assay—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system—
Proceed as directed in the
Assayunder
Dronabinol.
Assay preparation—
Weigh and mix the contents of not less than 20Capsules.Transfer an accurately weighed portion of the capsule contents,equivalent to about 20mg of dronabinol,to a 100-mLvolumetric flask,dilute with dehydrated alcohol to volume,and mix.
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Dronabinol.Calculate the quantity,in mg,of dronabinol (C
21H
30O
2)in the portion of Capsules taken by the formula:
100C(rU/rS),
in which
Cis the concentration,in mg per mL,of USP
D9-Tetrahydrocannabinol RSin the
Standard preparation,and
rUand
rSare the dronabinol peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.