Dronabinol Capsules
»Dronabinol Capsules contain dronabinol in sesame oil.Dronabinol Capsules contain not less than 90.0percent and not more than 110.0percent of C21H30O2.
Packaging and storage— Preserve in well-closed,light-resistant containers,in a cool place.
USP Reference standards á11ñ— USPD9-Tetrahydrocannabinol RS.
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.
Uniformity of dosage units á905ñ: meet the requirements.
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 (C21H30O2)in the portion of Capsules taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of USPD9-Tetrahydrocannabinol RSin the Standard preparation,and rUand rSare the dronabinol peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 704
Phone Number:1-301-816-8251