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Applicable in Products
| Item | Acceptance Limit | Result | |
|---|---|---|---|
| Physical Properties | Color | White to off-white | White |
| Form | Powder | Powder | |
| Assay(dry basis),w/% | 97.0%~102.0% | 99.05% | |
| N-[N-(3,3-Dimethylbutyl)-L-alpha-As partyl]-L-Phenylalanine,w/% | ≤1.5% | 0.25% | |
| Other Related Substances,w/% | |||
| ≤2.0% | 0.71% | ||
| Water ,25±5mg,w/% | ≤5.0% | 4.80% | |
| Lead/(mg/kg) | ≤1mg/kg | <1 mg/kg | |
| Arsenic(mg/kg) | ≤3mg/kg | <3 mg/kg | |
| Residue on Ignition, w/% | ≤0.2% | 0.10% | |
| PH ,0.5% Solution | 5.0～7.0 | 5.6 | |
| Residual Solvents | Methanol≤0.1% | 0.02% | |
| Ethanol≤0.1% | Not Detected | ||
| Specific Rotation (20C dried basis) | -43.4°ï½ž-40.0° | -41.2° | |
| Aerobic Plate Count | ≤250/g | <250/g | |
| Coliforms | ≤10/g | <10/g | |
| Fungi | ≤100/g | <100/g | |
| Melting Point | 80~83℃ | Conforms | |
| Conclusion: Conforms with above specification of USP 39/FCC 8th | |||
Nature of Business
Manufacturer / Exporter / Supplier / Retailer
Number of Employees
Below 20
Year of Establishment
2013
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