| Analysis Items | Specifications | Results | Test Methods | ||||
| Identification A: Chemical reaction B:IR | A blue color appears Corresponds qualitatively to the reference | Conforms Conforms | USP42-NF37 | ||||
| Appearance | Fine yellow to orange crystalline powder | Conforms | Organoleptic | ||||
| Assay |
CoQ10: 98.0%~101.0%
(anhydrous substance) |
99.89% | HPLC | ||||
| Chromatographic purity | The single related impurities ≤0.3% | 0.22% | HPLC | ||||
| Test 1:Coenzymes Q7, Q8, Q9, Q11 and related impurities ≤1.0% | 0.42% | HPLC | |||||
| Test 2: 2Z isomer and related im purities ≤ 1. 0% | 0.11% | HPLC | |||||
| Test 1 and Test 2 ≤1.5% | 0.53% | HPLC | |||||
| Residue Solvents | Ethanol ≤1,000ppm | 50ppm | GC | ||||
| Ethyl Acetate≤100ppm | <7.1ppm | GC | |||||
| N-Hexane≤20ppm | <0.1ppm | GC | |||||
| Water | NMT 0.2% | 0.01% | KF | ||||
| Residue on Ignition | NMT 0.1% | 0.03% | USP42 | ||||
| Residue Solvents | Ethanol ≤1,000ppm | 50ppm | GC | ||||
| Ethyl Acetate≤100ppm | <7.1ppm | GC | |||||
| N-Hexane≤20ppm | <0.1ppm | GC | |||||
| Heavy Metals | Inorganic Arsenic NMT 3ppm | <0.01ppm | USP42 | ||||
| Cadmium NMT 1ppm | <0.01ppm | USP42 | |||||
| Total Mercury NMT 3ppm | <0.01ppm | USP42 | |||||
| Lead NMT 1ppm | <0.01ppm | USP42 | |||||
| Microbiological Data | Total Plate Count ≤1,000cfu/g | <10cfu/g | USP42 | ||||
| Total Yeast & Mold ≤100cfu/g | <10cfu/g | USP42 | |||||
| Escherichia coli to be negative | Negative | USP42 | |||||
| Staphylococcus aureus to be negative | Negative | USP42 | |||||
| Salmonella to be negative | Negative | USP42 | |||||