Printed on: Sun Aug 08 2021, 04:08:10 AM Official Status: Currently Official on 08-Aug-2021 DocId: 1_GUID-A3679589-FF83-413A-A9DC-39CC366BEE43_2_en-US

(EST)
Printed by: Le Tran Official Date: Official Prior to 2013 Document Type: DIETARY SUPPLEMENTS @2021 USPC
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rU = peak area of ubidecarenone from the Sample

Ubidecarenone Tablets solution
DEFINITION rS = peak area of ubidecarenone from the Standard
Ubidecarenone Tablets contain NLT 90.0% and NMT 115.0% solution
of the labeled amount of ubidecarenone (C59H90O4). CS = concentration of USP Ubidecarenone RS in the
Standard solution (mg/mL)
IDENTIFICATION CU = nominal concentration of ubidecarenone in the
• A. The retention time of the major peak of the Sample Sample solution (mg/mL)
solution corresponds to that of the Standard solution, as
obtained in the Procedure for Strength. Acceptance criteria: 90.0%–115.0%
STRENGTH PERFORMANCE TESTS
• PROCEDURE • DISINTEGRATION AND DISSOLUTION á2040ñ: Meet the
[NOTE—Conduct this test promptly with minimum requirements of the test for Disintegration, except where
exposure to actinic light.] the product is labeled to contain a water-soluble form of
Solvent: n-Hexane and dehydrated alcohol (5:2) ubidecarenone. Tablets labeled to contain a water-soluble
Mobile phase: Acetonitrile, tetrahydrofuran, and water form of ubidecarenone meet the requirements for the test
(11:8:1) for Dissolution, as follows.
Standard stock solution: 1.0 mg/mL of USP Medium: Water; 500 mL
Ubidecarenone RS in Solvent Apparatus 2: 75 rpm
Standard solution: 40 µg/mL from Standard stock solution Time: 60 min
in dehydrated alcohol Standard solution: Dissolve 25 mg of USP
System suitability stock solution: 1.0 mg/mL of USP Ubidecarenone RS in 1 mL of ethyl ether, and dilute with

Ubidecarenone Related Compound A RS in Solvent. Dilute a
portion of this solution with dehydrated alcohol to obtain a
concentration of 40 µg/mL.
System suitability solution: Standard solution and System
suitability stock solution (1:1)
ci
Sample stock solution: Weigh and finely powder NLT 20
Tablets. Transfer a quantity of 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 min. Dilute with Solvent to volume, and mix.
ffi
Centrifuge a portion of this solution, transfer 1.0 mL of the
supernatant to a 25-mL volumetric flask, and add 2.5 mL
of a 0.1% solution of anhydrous ferric chloride in alcohol.
Dilute with alcohol to volume, and mix.
Sample solution: Centrifuge a portion of Sample stock
solution, transfer 1.0 mL of the supernatant to a 25-mL
O
al
alcohol to obtain a concentration of 2.5 µg/mL. [NOTE—Use
a freshly prepared solution only.]
Sample solution: Dilute with alcohol a volume of the
solution under test, previously passed through a suitable
filter of 0.45-µm pore size, to obtain a concentration of 2.5
µg/mL of ubidecarenone.
Mobile phase and Chromatographic system: Proceed as
directed in the Procedure for Strength, except for
Injection size.
Injection size: 100 µL
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
ubidecarenone (C59H90O4) dissolved:
Result = (rU/rS) × (CS × V × D/L) × 100

volumetric flask, add 2.5 mL of a 0.1% solution of

anhydrous ferric chloride in alcohol, and dilute with alcohol rU = peak area of ubidecarenone from the Sample
to volume. solution
Chromatographic system rS = peak area of ubidecarenone from the Standard
(See Chromatography á621ñ, System Suitability.) solution
Mode: LC CS = concentration of USP Ubidecarenone RS in the
Detector: UV 280 nm Standard solution (mg/mL)
Column: 8-mm × 10-cm; packing L1 V = volume of Medium, 500 mL
Flow rate: 2.5 mL/min D = dilution factor for the Sample solution
Injection size: 15 µL L = label claim (mg/Tablet)
System suitability
Samples: Standard solution and System suitability solution Tolerances: NLT 75% of the labeled amount of
Suitability requirements ubidecarenone (C59H90O4) is dissolved.
Resolution: NLT 2.5 between ubidecarenone and SPECIFIC TESTS
ubidecarenone related compound A, System suitability • WEIGHT VARIATION OF DIETARY SUPPLEMENTS á2091ñ :
solution Meet the requirements
Tailing factor: NMT 1.5, Standard solution
Relative standard deviation: NMT 2.0% for ADDITIONAL REQUIREMENTS
ubidecarenone, Standard solution • PACKAGING AND STORAGE: Preserve in tight, light-resistant
Analysis containers.
Samples: Standard solution and Sample solution • LABELING: Where the product contains a water-soluble form
Calculate the percentage of the labeled amount of of ubidecarenone, this is so stated on the label.
ubidecarenone (C59H90O4) in the portion of Tablets • USP REFERENCE STANDARDS á11ñ
taken: USP Ubidecarenone RS
USP Ubidecarenone Related Compound A RS
Result = (rU/rS) × (CS/CU) × 100 Coenzyme Q9.

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