Ubidecarenone Tablets
»Ubidecarenone Tablets contain not less than 90.0percent and not more than 115.0percent of the labeled amount of ubidecarenone (C59H90O4).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Disintegration and dissolution á2040ñ: meet the requirements of the test for Disintegrationonly.
Weight variation á2091ñ: meet the requirements.
Assay— [NOTE—Conduct this test promptly with minimum exposure to actinic light.]
Solvent,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Ubidecarenone Capsules.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed quantity of the powder,equivalent to about 100mg of ubidecarenone,to a 100-mLvolumetric flask,add 60mLof Solvent,and shake by mechanical means for 30minutes.Dilute with Solventto volume,and mix.Centrifuge a portion of this solution,transfer 1.0mLof the supernatant to a 25-mLvolumetric flask,add 2.5mLof a 0.1%solution of anhydrous ferric chloride in alcohol,dilute with alcohol to volume,and mix.
Procedure— Separately inject equal volumes (about 15µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of ubidecarenone (C59H90O4)in the portion of Tablets taken by the formula:
2500C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Ubidecarenone RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2133
Pharmacopeial Forum:Volume No.27(2)Page 2267
Phone Number:1-301-816-8389