Dihydrotachysterol Capsules
»Dihydrotachysterol Capsules contain a solution of Dihydrotachysterol in a suitable vegetable oil.Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C28H46O.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification—
A: Cut open 1Capsule,and remove the contents:the Capsule contents respond to Identificationtest Aunder Dihydrotachysterol Oral Solution.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phase ,Standard preparation,System suitability preparation,and Chromatographic system—Prepare as directed in the Assayunder Dihydrotachysterol.
Assay preparation— Combine the contents of not less than 20Capsules.Transfer an accurately weighed quantity of Capsule contents,equivalent to about 500µg of dihydrotachysterol,to a 50-mLvolumetric flask,dissolve in 25mLof Mobile phase,and mix.Dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Dihydrotachysterol.Calculate the quantity,in µg,of C28H46Oin the portion of Capsules taken by the formula:
50C(rU/rS),
in which Cis the concentration,in µg per mL,of USP Dihydrotachysterol RSin the Standard preparation,and rUand rSare the 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 651
Phone Number:1-301-816-8251