Analysis Items | Specifications | Methods |
Identifications |
- NMR
| 1H NMR confirms to product structure. |
- LC-MS
| LC-MS Conforms to molecular weight. |
- HPLC
| Retention time of the sample matches with the RS in HPLC purity test. |
Physical Tests |
Appearance | Beige to light yellow powder | Visual |
Melting point | 65~67℃ | GB 617 |
Bulk density | 0.30-0.60g/mL | GB 5009.2 |
Moisture content | ≤0.50% | GB 5009.3 |
Residue on ignition | ≤0.50% | GB 5009.4 |
Active Ingredients Tests |
Urolithin A Purity | ≥98.00% | HPLC |
Max Single impurity | ≤1.00% | HPLC |
Chemical Tests |
Heavy Metals | ≤10.00ppm | GB 5009.74 |
Pb<Lead> | ≤3.00ppm | GB 5009.12 |
As<Inorganic arsenic> | ≤2.00ppm | GB 5009.11 |
Cd<Cadmium> | ≤1.00ppm | GB 5009.15 |
Hg<Total mercury> | ≤0.10ppm | GB 5009.17 |
Residue of Methanol | ≤3,000ppm | GB 5009.262 |
Residue of DMSO | ≤5,000ppm | GB 5009.262 |
Residue of Acetic Acid | ≤5,000ppm | GB 5009.262 |
Microbiological Tests |
Total Bacterial Counts | ≤1,000cfu/g | GB 4789.2 |
Yeasts and Molds | ≤100cfu/g | GB 4789.15 |
Coliform group | ≤1.0MPN/g | GB 4789.3 |
Salmonella | Negative in 10g | GB 4789.4 |
* Conclusion: Conform to above specifications. |
* Packaging: 20/25kg per fiber drum. |
* Storage Condition: Preserve in well-closed, tight containers with temperature below 10℃. |
* Shelf Life: 3 years when properly stored. |