| CAS No.: | 303-98-0 |
|---|---|
| Formula: | C59h90o4 |
| EINECS: | 206-147-9 |
| Packaging Material: | Paper Box/Drum |
| Storage Method: | in Dark and Dry |
| Shelf Life: | 2 Years |
| Samples: |
|---|
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Audited Supplier | 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 | |||
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