Ubidecarenone
C59H90O4
![]() ![]() ![]() ![]() ![]() 2,5-Cyclohexadiene-1,4-dione, 2-[(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-2,6,10,14,18,22,26,30,34,38-tetracontadecaenyl]-5,6-dimethoxy-3-methyl. 2-[(all-E)-3,7,11,15,19,23,27,31,35,39-Decamethyl-2,6,10,14,18,22,26,30,34,38-tetracontadecaenyl)-5,6-dimethoxy-3-methyl-p-benzoquinone ![]() ![]() ![]() » Ubidecarenone (Coenzyme Q10) contains not less than 98.0 percent and not more than 101.0 percent of C59H90O4, calculated on the anhydrous basis.
Packaging and storage
Preserve in well-closed, light-resistant containers.
USP Reference standards
![]() ![]() USP Ubidecarenone RS. USP Ubidecarenone Related Compound A RS ![]() USP Ubidecarenone for System Suitability RS.
Identification
B:
Dissolve about 50 mg of Ubidecarenone in 1 mL of ethyl ether, and add 10 mL of dehydrated alcohol. To 2 mL of this solution, add 3 mL of dehydrated alcohol and 2 mL of dimethyl malonate, add 1 mL of potassium hydroxide solution (1 in 5) dropwise, and mix: a blue color appears.
Water, Method I
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Residue on ignition
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Heavy metals, Method II
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Chromatographic purity
test 1: coenzymes Q7, Q8, Q9, Q11 and related impurities
Mobile phase
Proceed as directed in the Assay.
Chromatographic system
Proceed as directed in the Assay. To evaluate the system suitability requirements, use the System suitability preparation, as prepared in the Assay.
Standard solution and Test solution
Use the Standard preparation and the Assay preparation, as prepared in the Assay.
Procedure
Proceed as directed in the Assay, measure all the peak areas, and calculate the percentage of impurities in the portion of Ubidecarenone taken by the formula:
100(ri / rs)
in which ri is the sum of all peak responses, other than that for ubidecarenone, obtained from the Test solution; and rs is the sum of all peak responses. Not more than 1.0% is found.
test 2: ubidecarenone (2Z)-isomer and related impurities
Mobile phase
Prepare a filtered and degassed mixture of n-hexane and ethyl acetate (97:3).
System suitability solution
Prepare a solution of USP Ubidecarenone for System Suitability RS in n-hexane having a concentration of about 1 mg per mL.
Test solution
Prepare a solution of Ubidecarenone in n-hexane having a concentration of about 1 mg per mL.
Chromatographic system
The liquid chromatograph is equipped with a 275-nm detector and a 4.6-mm × 25-cm column that contains packing L3. The flow rate is about 2.0 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.85 for ubidecarenone (2Z)-isomer and 1.0 for ubidecarenone; and the resolution, R, between ubidecarenone (2Z)-isomer and ubidecarenone is not less than 1.5.
Procedure
Inject a volume of the Test solution (about 20 µL) into the chromatograph, record the chromatogram, and measure all the peak responses. Calculate the percentage of impurities in the portion of Ubidecarenone taken by the formula:
100(ri / rs)
in which ri is the sum of all peak responses, other than that for ubidecarenone; and rs is the sum of all peak responses. Not more than 1.0% is found.
Calculate the percentage of total impurities as the sum of the percentages obtained by Test 1 and Test 2: not more than 1.5% of total impurities is found.
Assay
Mobile phase
Prepare a filtered and degassed mixture of methanol and dehydrated alcohol (13:7). Make adjustments if necessary (see System Suitability under Chromatography
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System suitability preparation
Dissolve accurately weighed quantities of USP Ubidecarenone RS and USP Ubidecarenone Related Compound A RS in dehydrated alcohol, heating at about 50
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Standard preparation
Dissolve an accurately weighed quantity of USP Ubidecarenone RS in dehydrated alcohol, heating at about 50
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Assay preparation
Transfer about 50 mg of Ubidecarenone, accurately weighed, to a 50-mL volumetric flask, dissolve in dehydrated alcohol, heating at about 50
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Chromatographic system (see Chromatography
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Procedure
Separately inject equal volumes (about 5 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 C59H90O4 in the portion of Ubidecarenone taken by the formula:
50C(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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1079
Pharmacopeial Forum: Volume No. 31(1) Page 86
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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