| ≥1 piece |
|
Specification |
CAS |
Value UoM |
|
appearance |
White powder |
White powder |
|
Assay |
98.5-102.0 % |
99.07 |
|
Specific Rotation ［a］D20℃ |
+14.5~+16.5 |
15.2 |
|
Transmittance |
≥0.950 |
0.996 |
|
5-benzy1-3,6dioxo-2-piperazineacetic Acid : |
≤1.5% |
0.29% |
|
FCCIV Other related substances: |
≤2.0% |
0.36 |
|
Loss on drying |
≤4.5% |
1.8% |
|
Residue on Ignition |
≤0.2% |
0.09% |
|
Heavy metals |
≤10mg/kg |
<10mg/kg |
|
Lead |
≤1mg/kg |
<1mg/kg |
|
USP24 Organic volatile impurities |
Passes |
Passes |
|
Conclusion |
The results above meet the requirements of FCCIV |
|