| Production Name | Coenzyme Q10 | CAS No. | 303-98-0 | ||||
| Batch No. | 220717A | Formula | C59H90O4 | ||||
| MFG. Date | Jul. 18,2022 | Quantity | 900kg | ||||
| Expiry Date | Jul. 17,2024 | Report Date | Jul.18,2022 | ||||
| Test Items | Specifications | Results | Standard | ||||
| Appearance | Yellow to orange yellow crystalline powder | Orange yellow crystalline powder | Visual | ||||
| Solubility | Soluble in ether, trichloromethae and acetone; very slightly soluble in dehydrated alcohol; practically insoluble in water | Complies | USP | ||||
| Identification | A: IR spectrum must be corresponded to that reference standard | Complies | USP<197k> | ||||
| B: A blue color appears in identification test B | Complies | USP | |||||
| Water | ≤0.20% | 0.09% | USP<921>IC | ||||
| Residue on ignition | ≤0.10% | 0.03% | USP<281>IC | ||||
| Melting point | 48℃-52℃ | 49.5℃-50.5℃ | USP<741> | ||||
| Particle size | 90% pass through 80 meshes | 95.4% | USP<786> | ||||
| Assay | 98.0-101.0%(on the anhydrous basis) | 99.0% | USP<621> | ||||
| Related Substances | Procedure 1: Q7.8.9.11 and Related impurities≤1.0% | 0.61% | USP<621> | ||||
| Procedure 2: Ubidecarenone (2Z) -isomer and related impurities≤1.0% | 0.28% | USP<621> | |||||
| Total impurities 1+2≤1.0% | 0.89% | USP<621> | |||||
| Residual solvents | N-hexane | ≤290 ppm | 1.3 ppm | USP<467> | |||
| Ethyl alcohol | ≤5000 ppm | 47.0 ppm | USP<467> | ||||
| Methanol | ≤2000 ppm | 37.0 ppm | USP<467> | ||||
| Isopropyl ether | ≤300 ppm | Absent | USP<467> | ||||
| Elemental impurities | Total heavy metals | ≤10 ppm | ≤10 ppm | USP<2231>II | |||
| Arsenic(inorganic) | ≤1.5 ppm | <1.5 ppm | USP<2232> | ||||
| Cadmium | ≤0.5 ppm | <0.5 ppm | USP<2232> | ||||
| Lead | ≤0.5 ppm | <0.5 ppm | USP<2232> | ||||
| Mercury(total) | ≤1.5 ppm | <1.5 ppm | USP<2232> | ||||
| Methylmercury(as Hg) | ≤0.2 ppm | <0.2 ppm | USP<2232> | ||||
| Microbiological tests | Total aerobic bacteria | ≤1000 cfu/g | <10 cfu/g | USP<2021> | |||
| Mold and yeast count | ≤50 cfu/g | <10 cfu/g | USP<2021> | ||||
| Escherichia coli | Absent / 10g | Absent | USP<2022> | ||||
| Salmonella | Absent / 25g | Absent | USP<2022> | ||||
| Staphylococcus aureus | Absent / 25g | Absent | USP<2022> | ||||
| Conclusion | Complies with Enterprise Standard | ||||||
