Ubidecarenone Capsules
DEFINITION
Ubidecarenone Capsules contain NLT 90.0% and NMT 115.0% of the labeled amount of ubidecarenone (C59H90O4).
IDENTIFICATION
• A.
The retention time of the major peak of either Sample solution 1 or Sample solution 2 corresponds to that of the Standard solution, as obtained in the Procedure for Strength.
STRENGTH
• Procedure
[Note—Conduct this test promptly with minimum exposure to actinic light. ]
Solvent:
n-Hexane and dehydrated alcohol (5:2)
Mobile phase:
Acetonitrile, tetrahydrofuran, and water (55:40:5)
Standard stock solution:
1.0 mg/mL of USP Ubidecarenone RS in Solvent
Standard solution:
40 µg/mL in dehydrated alcohol, from the Standard stock solution
System suitability stock solution:
1.0 mg/mL of USP 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)
Sample solution 1 (for soft gelatin Capsules):
Open a number of Capsules equivalent to 200 mg of ubidecarenone, quantitatively transfer the shells and contents to a container, add 100 mL of Solvent, and shake by mechanical means for 30 min. Using small portions of Solvent, quantitatively transfer this mixture to a 200-mL volumetric flask, and dilute with Solvent to volume. 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, and dilute with alcohol to volume.
Sample solution 2 (for hard gelatin Capsules):
Empty and thoroughly mix the contents of NLT 20 Capsules. Transfer a portion of the powder, equivalent to 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. 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, and dilute with alcohol to volume.
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
8-mm × 10-cm; packing L1
Flow rate:
2.5 mL/min
Injection size:
15 µL
System suitability
Samples:
Standard solution and System suitability solution
Suitability requirements
Resolution:
NLT 2.5 between ubidecarenone and ubidecarenone related compound A, System suitability solution
Tailing factor:
NMT 1.5, Standard solution
Relative standard deviation:
NMT 2.0% for ubidecarenone, Standard solution
Analysis
Samples:
Sample solution 1 or Sample solution 2, and Standard solution
Calculate the percentage of the labeled amount of ubidecarenone (C59H90O4) in the portion of Capsules taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area of ubidecarenone from Sample solution 1 or Sample solution 2 |
| rS | = | = peak area of ubidecarenone from the Standard solution |
| CS | = | = concentration of USP Ubidecarenone RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of ubidecarenone in Sample solution 1 or Sample solution 2 (mg/mL) |
Acceptance criteria:
90.0%–115.0%
PERFORMANCE TESTS
• Disintegration and Dissolution 
2040
:
Meet the requirements of the test for Disintegration, except where the product is labeled to contain a water-soluble form of ubidecarenone. Capsules labeled to contain a water-soluble form of ubidecarenone meet the requirements for the test for Dissolution, as follows.
2040:
Meet the requirements of the test for Disintegration, except where the product is labeled to contain a water-soluble form of ubidecarenone. Capsules labeled to contain a water-soluble form of ubidecarenone meet the requirements for the test for Dissolution, as follows.
Medium:
Water; 500 mL
Apparatus 2:
75 rpm
Time:
60 min
Standard solution:
Dissolve 25 mg of USP Ubidecarenone RS in 1 mL of ethyl ether, and dilute with 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
| rU | = | = peak area of ubidecarenone from the Sample solution |
| rS | = | = peak area of ubidecarenone from the Standard solution |
| CS | = | = concentration of USP Ubidecarenone RS in the Standard solution (mg/mL) |
| V | = | = volume of Medium, 500 mL |
| D | = | = dilution factor for the Sample solution |
| L | = | = label claim (mg/Capsule) |
Tolerances:
NLT 75% of the labeled amount of ubidecarenone (C59H90O4) is dissolved.
SPECIFIC TESTS
• Weight Variation 2091:
Meet the requirements
2091:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
Where the product contains a water-soluble form of ubidecarenone, this is so stated on the label.
• USP Reference Standards 11
11
USP Ubidecarenone RS 
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USP Ubidecarenone Related Compound A RS
Coenzyme Q9.
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Coenzyme Q9.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1461
Pharmacopeial Forum: Volume No. 33(1) Page 93