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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
| 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% |
| 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 | ||
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Key to abbreviations
BP = British Pharmacopoeia
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia