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 and acetone;very slightly soluble indehydrated alcohol;practically insoluble in water | USP<1171> |
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> |