Coenzyme Q10 (Ubiquinone)
Ville: LV, Marupe
Physical Properties
Test | Specification | Result | Standard Referenced |
Appearance | Yellow to orange crystalline powder | Complies | Visual |
Odor | Characteristic | Complies | Sensory |
Loss on drying | ≤0.2% | 0.01% | 2g/105℃/5hrs |
Residue on Ignition | ≤0.1% | 0.01% | 2g/800℃/5hrs |
Melting point | 48℃~52℃ | 49.2℃~50.7℃ | USP |
Loose density | / | 0.2562 g/ml | W/V |
Tapped density | / | 0.4122 g/ml | W/V |
Particle Size | ≥90% pass 80 mesh | Complies | USP |
Identification
Test | Specification | Result | Standard Referenced |
IR spectrum | Corresponds to reference standard | Complies | USP |
Color reaction | A blue color appears | Complies | USP |
Chemical Tests
Test | Specification | Result | Standard Referenced |
Heavy metals | ≤10 mg/kg | Complies | USP |
Arsenic (As) | ≤1.0 mg/kg | Complies | USP |
Lead (Pb) | ≤0.5 mg/kg | Complies | USP |
Cadmium (Cd) | ≤0.5 mg/kg | Complies | USP |
Mercury (Hg) | ≤0.1 mg/kg | Complies | USP |
Methanol | ≤3000 ppm | Complies | USP |
Ethanol | ≤1000 ppm | 22.4 ppm | USP |
Hexane | ≤1 ppm | 0.2 ppm | USP |
Isopropyl ether | ≤300 ppm | Complies | USP |
Assay
Test | Specification | Result | Standard Referenced |
Q10 (anhydrous basis) | 98%~101% | 99.17% | USP |
Impurities
Test | Specification | Result | Standard Referenced |
Coenzymes Q7~Q11 & related impurities | ≤1.0% | 0.53% | USP |
Ubidecarenone (2Z)-Isomer | ≤0.5% | 0.20% | USP |
Total impurities | ≤1.5% | 0.71% | USP |
Microbiological Tests
Test | Specification | Result | Standard Referenced |
Total plate count | ≤1000 CFU/g | <10 CFU/g | GB 4789.2 |
Yeast & Mould | ≤100 CFU/g | <10 CFU/g | GB 4789.15 |
Coliforms | Negative/10g | Negative | GB 4789.3 |
Salmonella | Negative/25g | Negative | GB 4789.4 |
S. aureus | Negative/25g | Negative | GB 4789.10 |
Else
Storage condition | Seal and store in a cool and dry place, avoiding direct sunlight |
Shelf life | 3 years when properly stored |