Product Name | Coenzyme Q10 | Specification | 98% |
Batch No. | VQ2105001 | Manufacturing Date | 2021-5-5 |
Analysis Date | 2021-5-5 | Expiry Date | 2024-5-4 |
ltems | Methods | Specifications | Results |
Description | Visual | Orange Yellow Fine Powder | Orange YellowPowder |
Melting Point | USP/EP | 48ºC-52ºC | Conforms |
ldentification | USP/EP | IR:IRspectrum of the test specimen should be consistent withthelRspectrumof reference standard | Conforms |
Color Reaction: A blue color appears | Conforms | ||
Assay (Coenzyme Q10> | HPLC | ≥98.0% | 99.2% |
Total impurities | HPLC | ≤1.5% | 0.61% |
Loss on Drying | USP/EP | ≤0.2% | 0.14% |
Sieve Analysis | USP/EP | 100% pass No.80 | Conforms |
Residue on ignition | USP/EP | ≤0.1% | 0.04% |
Lead(as Pb) | USPEP | ≤3.0mg/kg | <0.5mg/kg |
Arsenic (as As) | USP/EP | ≤1.0mg/kg | <1.0mg/kg |
Cadmium (as Cd) | USP/EP | ≤1.0mg/kg | <0.5mg/kg |
Mercury (as Hg) | USP/EP | ≤0.1mg/kg | <0.1mg/kg |
Tapped Density | USP/EP | 0.40g/ml-0.60g/ml | 0.46g/ml |
Residual Solvents | USP/EP | Ethanol s5000ppm | 97ppm |
Ethyl acetate <5000ppm | Not detected | ||
N-Hexane s290ppm | Not detected | ||
N-Heptane <5000ppm | 214ppm | ||
Pesticides Residue | USP/EP | Conforms | |
Chromatographic purity | CoenzymeQ7,Q8,Q9,Q11 and related impurities<1.0% | 0.74% | |
Ubidecarenone (2z) -lsomer and related impurities s0.5% | 0.26% | ||
Totalimpurities ( Test1- 2 ) ≤1.5% | 1% | ||
Microbial Test | |||
Total aerobic microbial count | USP<2021> EP2.6.12 | ≤1000cfulg | <100cfulg |
Total moulds & yeasts count | USP<2021> EP2.6.12 | <50cfu/g | <10cfu/g |
*Salmonella | USP<2022> EP2.6.13 | Absence | Absence |
*Escherichia coli | USP<2022> EP2.6.13 | Absence | Absence |
*Staphylococcus aureus | uSP<2022> EP2.6.13 | Absence | Absence |
Conclusion: Conform to USP/EP |