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Ubiquinol-10

Compositional guideline for 'Ubiquinol-10' permitted for use in listed medicines

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Name of the ingredient

Ubiquinol-10 (AAN)

Definition of the ingredient

Ubiquinol-10 is 2-[(all-E)-3,7,11,15,19,23,27,31,35,39-decamethyltetraconta-2,6,10,14,18,22,26,30,34,38-decaenyl]-1,4-dihydroxy-5,6-dimethoxy-3-methylbenzene. Ubiquinol-10 is a single stereoisomer having the (E)-configuration (trans) at each of the double bonds.

Ubiquinol-10 is made via a yeast fermentation process. The substance is anhydrous with no water of hydration.

Molecular formula: C59H92O4

Molecular mass: 865.37

CAS Number: 992-78-9

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual White to pale yellow solid
Characteristics
Melting point BP (Appendix V A) 49.5°C
Solubility BP (general notice) Very soluble in toluene and ethyl acetate, freely soluble in hexane, sparingly soluble in ethanol, very slightly soluble in methanol, practically insoluble in water
Stability   Readily oxidised in air (converts to ubidecarenone); adversely affected by light and moisture
Identification
Ubiquinol-10 IR absorbance spectrum with potassium bromide (BP, Appendix II A) Complies with standard
Assay
Ubiquinol-10 HPLC 96.0-102.0%
Table 2: Incidental constituents
Test Method reference Acceptance criteria
Residual solvents
Ethanol BP (Appendix VIII L) Not more than 100 ppm
Incidental metals and non-metals
Heavy metals Ph Eur method 2.4.8 Not more than 20 ppm
Other organic or inorganic impurities or toxins
Ubidecarenone HPLC Not more than 2.0%
Water Karl Fischer Not more than 0.3%
Residue on ignition USP <281> Not more than 0.2%
Total other impurities1 HPLC Not more than 1.0%
Other individual impurity HPLC Not more than 0.5%
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.
Notes
  1. Typically comprise the reduce form of Coenzyme Q9 (that is, the reduced form of impurity D as described in Ph Eur for Ubidecarenone), and to a lesser extent the cis-isomer of Ubiquinol-10.

Key to abbreviations

BP = British Pharmacopoeia

HPLC = High-pressure liquid chromatography

IR = Infrared spectrophotometry

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia

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