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Food and Cosmectic Grade Coenzyme Q10 (CoQ10)
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Product Description
Product Name: | Coenzyme Q10(Ubidecarenone) | Batch No.: | 160319 |
Manufacture Date: | Mar.19,2016 | Expiry Date: | Mar.18,2019 |
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Items | Specifications | Results | Methods |
Description | Yellow-orange crystalline powder | Yellow-orange crystalline powder | |
Melting point | 48ºC~52ºC | 50ºC~50.5ºC | USP(741) |
Solubility | Soluble in ether; very slightly soluble in dehydrated alcohol; practically insoluble in water | conform | |
Identification IR | Sample spectrum consistent with the spectrum for USP reference Standard | Conform | USP(197K) |
Color reaction | A blue color appears | conform | |
Sieve | 100% pass 80 mesh 90% pass 100 mesh | conform | USP(786) |
Trapped Density | 0.40g/ml~0.60g/ml | 0.47g/ml | USP(616)I |
Water(KF) | ≤0.2% | 0.01% | USP(921) IC |
Residue on ignition | ≤0.1% | 0.06% | USP(281) |
Heavy metals | ≤10ppm | <10ppm | USP(231)II |
Pb | ≤0.5ppm | <0.5ppm | USP(2232) |
Hg | ≤0.1ppm | <0.1ppm | |
Cd | ≤0.5ppm | <0.5ppm | |
As | ≤1.0ppm | <1.0ppm | |
Chromatographic Purity | | | USP(621) |
Coenzymes Q7,Q8,Q9,Q11 and related impurities | ≤1.0% | 0.75% | |
Ubidecarenone(2Z)-isomer and related impurities | ≤1.0% | 0.35% | |
Total impurities | Total 1&2: ≤1.5% | 1.1% | |
Residual Solvents | | | |
Methanol | ≤3000ppm | 7ppm | |
n-Hexane | ≤290ppm | 1ppm | |
Ethanol | ≤5000ppm | 37ppm | |
Isopropyl ether | ≤300ppm | Not detected | |
Assay (on the anhydrous basis) | 98.0~101.0% | 99.0% | USP(621) |
Microbial limit test | | | |
Total plate count | ≤1000cfu/g | 5cfu/g | USP(2021) |
Yeast & mold count | ≤100cfu/g | <10cfu/g | USP(2021) |
E.coli | Absent/10g | Not detected | USP(2022) |
Salmonella | Absent/10g | Not detected | USP(2022) |
Bile-tolerant gram negative bacteria | ≤100MPN/g | <1MPN/g | USP(2021) |
Staphylococcus aureus | Absent/10g | Not detected | USP(2022) |
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