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Item | Specification | Results | ||
Assay (Anhydrous basis) | 98.0%-101.0% | 99.6% | ||
Decription | Yellow-orange crystalline powder | Visual | ||
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> | ||
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 | ≤20ppm | USP<467> | ||
Ethanol | ≤1000ppm | 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> |