| ANALYSIS | SPECIFICATION | RESULTS |
| Assay (Anhydrous basis) | 98.0%-101.0% | USP<621> |
| Decription | Yellow-orange crystalline powder | Visual |
| Melting Point | 48ºC-52ºC | USP<741> |
| Solubility | Soluble in ether;trichlorotethane | USP<1171> |
| and acetone;very slightly soluble indehydrated alcohol;practically insoluble in water |
| IR | Sample spectrum consistent with the spectrum for USP Reference Standard | USP<197K> |
| Color reaction | A blue color appears | USP<197K> |
| Sieve | 100%pass 80 mesh | USP<786> |
| 90%pass 100 mesh | USP<786> |
| Tapped Density | 0.40g/ml~0.60g/ml | USP<616> I |
| Water(KF) | ≤0.2% | USP<921> IC |
| Residue on Ignition | ≤0.1% | USP<281> |
| Chromatographic Purity Coenzymes Q7,Q8,Q9,Q11 and related impurities | ≤1.0% | USP<621> |
| Ubidecarenone(2Z)-isomer and related impurities | ≤0.5% | USP<621> |
| Total impurities | Total 1&2≤1.5% | USP<621> |
| Residual Solvents |
| Methanol | ≤3000ppm | USP<467> |
| n-Hexane | ≤290ppm | USP<467> |
| Ethanol | ≤5000ppm | USP<467> |
| Isopropyl ether | ≤300 ppm | USP<467> |
| Heavy Metals |
| Heavy Metal | <10ppm | USP<2232> |
| As | <1ppm | USP<2232> |
| Cd | ≤0.5ppm | USP<2232> |
| Pb | ≤ 0.5ppm | USP<2232> |
| Hg | ≤ 0.1ppm | USP<2232> |
| Microbial limit test |
| Total Aerobic Microbial | <1000cfu/g | USP<2021> |
| Yeast&Mold Count | <50cfu/g | USP<2021> |
| E.Coli | Absent/10g | USP<2022> |
| Salmonella | Avsent/25g | USP<2022> |
| Bile-tolerant gram negative bacteria | <1MPN/g | USP<2021> |
| Staphylococcus aureus | Avsent/25g | USP<2022> |
| Pseudomonas aeruginosa | Absent/10g | USP<62> |
Complaint
