Idebenone Impurities

Idebenone is a synthetic short-chain benzoquinone and a structural analog of coenzyme Q10 (ubiquinone). It is used as a neuroprotective and antioxidant agent, primarily in the management of neurological and mitochondrial disorders.
Idebenone works by:
∙ Supporting mitochondrial electron transport, thereby enhancing cellular energy (ATP) production
∙ Acting as a potent antioxidant, reducing oxidative stress in cells
Indications and uses include:
∙ Leber’s Hereditary Optic Neuropathy (LHON) (approved in the EU)
∙ Friedreich’s ataxia and other mitochondrial diseases (investigational)
∙ Skin and cosmetic products for anti-aging (due to its antioxidant effect)
Available in oral formulations (tablets or capsules), and occasionally topical formulations in the cosmetic industry.

Structure

Product Name

CAS No.

Cat No.

Action

Idebenone Impurity 10

Idebenone Impurity 10

Parent: Idebenone

CAS No.: 77712-34-6

Cat No.: VE0028519

Idebenone Impurity 11

Idebenone Impurity 11

Parent: Idebenone

CAS No.: 77712-29-9

Cat No.: VE0028520

Idebenone Impurity 13

Idebenone Impurity 13

Parent: Idebenone

CAS No.: 849703-44-2

Cat No.: VE0028521

Idebenone Impurity 14

Parent: Idebenone

CAS No.: 89048-27-1

Cat No.: VE0028522

Idebenone Impurity 15

Parent: Idebenone

CAS No.: 116460-82-3

Cat No.: VE0028523

Idebenone Impurity 2

Parent: Idebenone

CAS No.: N/A

Cat No.: VE0014983

Idebenone Impurity 4

Parent: Idebenone

CAS No.: 88543-34-4

Cat No.: VE0028515

Idebenone Impurity 6 (Mixture of Isomers)

Parent: Idebenone

CAS No.: N/A

Cat No.: VE0014984

Idebenone Reference Standard

Parent: Idebenone

CAS No.: 58186-27-9

Cat No.: VE0028518

Idebenone Related Compound 1 (Dipotassium Salt)

Parent: Idebenone

CAS No.: 95233-65-1

Cat No.: VE0014986

Idebenone-D-Glucuronide

Parent: Idebenone

CAS No.: N/A

Cat No.: VE0014985

Idebenone Related Compound

Impurities in idebenone may arise during chemical synthesis, storage, or formulation. Proper control and identification are necessary as per ICH Q3A/B and regulatory standards.

Types of Impurities in Idebenone

Process-Related Impurities

Unreacted starting materials (e.g., quinone derivatives)
By-products from side-chain alkylation, esterification, or oxidation steps
Residual solvents like methanol, ethyl acetate, or acetone

Degradation Impurities

Hydrolysis of ester functional groups
Oxidative degradation under exposure to air or light, leading to over-oxidized or polymerized quinones
Color changes may indicate product instability due to quinone decomposition

Elemental Impurities

Trace metals such as copper, nickel, or iron introduced from reaction vessels or catalysts

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC)
Liquid Chromatography–Mass Spectrometry (LC-MS)
Gas Chromatography (GC) for volatile solvents
Nuclear Magnetic Resonance (NMR)
ICP-MS for elemental impurity profiling

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