| Items | Specification | Results | Methods |
| Description | Yellow-orange crystalline powder | Orange crystalline powder | |
| Melting point | 48°C~52-C | 50.0X:-50.5.C | USP (741) |
| Solubility | Soluble in ether,trichloromethane | ||
| and acetone;very slightly soluble in | |||
| dehydrated alcohol; practically | Conform | ||
| insoluble in water | |||
| Identification | |||
| IR | Sample spectrum consistent with the | USP (197K> | |
| spectrum for USP Reference | Conform | ||
| Standard | |||
| Color reaction | A blue color appears | Conform | |
| Sieve | 100% pass 80 mesh | ||
| 90% pass 100 mesh | Conform | USP (786) | |
| Tapped Density | 0.40g/ml -0.60g/ml | 0.48g/ml | USP (616) I |
| Water (KF) | ≤0.20% | 0.03% | USP (921) IC |
| Residue on ignition | ≤0.10% | 0.08% | USP(281) |
| Heavy metals | ≤10ppm | <10 ppm | USP (231) II |
| Lead (Pb) | ≤0.5ppm | <0.5ppm | USP (2232) |
| Mercury (Hg) | ≤0.1ppm | <0.1ppm | |
| Cadmium (Cd) | ≤0.5ppm | <0.5ppm | |
| Arsenic(As) | ≤1.0ppm | <1.0ppm | |
| Chromatographic Purity | , | USP (621) | |
| Coenzymes Q7,Q8,Q9,Q11 | ≤ 1.0% | 0.66% | |
| and related impurities | |||
|
Ubidecarenone
(2Z)-isomer |
≤0.5% | 0.22% | |
| and related impurities | |||
| Total impurities | Total 1& 2: ≤1.5% | 0.88% | |
| Residual Solvents | USP (467) | ||
| Methanol | ≤3000ppm | 5ppm | |
| n-Hexane | ≤290ppm | 3ppm | |
| Ethanol | ≤5000ppm | 9ppm | |
| Isopropyl ether | ≤300ppm | Not detected | |
|
Assay
(on the anhydrous basis) |
98.0-101.0% | 99.4% | USP621) |
| Microbial limit test | |||
| TotalAerobic Microbial | ≤ 1000cfu/g | <10cfu/g | USP2023) |
| Count | |||
| Yeast & Mold Count | ≤50cfu/g | <10cfu/g | USP (2023) |
| E. coli ^ | Absent/l0g | Not detected | USP (2023) |
| Salmonella | Absent /25g | Not detected | USP (2023) |
| Bile-tolerantgram negative | ≤ 10MPN/g | < 10MPN/g | USP (2023) |
| bacteria | |||
| Staphylococcus aureus | Absent /25g | Not detected | USP (2023) |
| Pseudomonas aeruginosa | Absent /10g | Not detected | USP (62) |