Test items | Specifications | Results |
Assay(dry basis) | 97.0~102.0% | 99.83% |
N-[N-(3,3-Dimethylbutyl)-L-alpha-Aspartyl]-L-Phenylalanine. | ≤1.5% | 0.15% |
Other Related Substances | ≤2.0% | 0.22% |
PH, 0.5% solution | 5.0~7.0 | 5.3 |
Water, 25±5mg | ≤5.0% | 4.16% |
Residue on lgnition | ≤0.2% | 0.00% |
Specific Rotation [α]20D 0.5% solution , on dry basis | -43.4~-40.0 | -41.2 |
Melting Point | 81ºC~-84ºC | 83ºC |
Lead | ≤1mg/kg | 0.03mg/kg |
Arsenic | ≤3mg/kg | 0.80mg/kg |
Aerobic Plate Count | <250cfu/g | <250cfu/g |
Coliforms | <10mpn/g | <10mpn/g |
Fungi | <100cfu/g | <100cfu/g |
Shigella | None | None |
Salmonella | None | None |
Staphylococcus aureus | None | None |
Conclusion : The test results comply with USP/FCC VIII standard |