» Ubidecarenone Tablets contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ubidecarenone (C59H90O4).
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Where the product contains the water-soluble form of ubidecarenone, this is so stated in the label.
USP Reference standards 11
USP Ubidecarenone RS.
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Disintegration and dissolution 2040: meet the requirements of the test for Disintegration only, except where the product is labeled to contain the water-soluble form of ubidecarenone. Ubidecarenone Tablets labeled to contain the water-soluble form of ubidecarenone meet the requirements for Dissolution as directed in the test for Disintegration and dissolution under Ubidecarenone Capsules.
Weight variation 2091: meet the requirements.
Assay [noteConduct this test promptly with minimum exposure to actinic light.]
Solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Ubidecarenone Capsules.
Assay preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 100 mg of ubidecarenone, to a 100-mL volumetric flask, add 60 mL of Solvent, and shake by mechanical means for 30 minutes. Dilute with Solvent to volume, and mix. Centrifuge a portion of this solution, transfer 1.0 mL of the supernatant to a 25-mL volumetric flask, add 2.5 mL of a 0.1% solution of anhydrous ferric chloride in alcohol, dilute with alcohol to volume, and mix.
Procedure Separately inject equal volumes (about 15 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg per mL, of USP Ubidecarenone RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 1081Pharmacopeial Forum: Volume No. 33(1) Page 94