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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°~-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 |