 |
| Menge: | |
|---|---|
DY12019
129722-12-9
C23H27Cl2N3O2
Aripiprazole
| Index Name | Specifications |
| Appearance | White crystalline powder |
| Identification | According to IR |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.1% max |
| Melting point | 136 to 140degC |
| Heavy metals | 20ppm max |
| Related substance | Any single impurity:0.5% max |
| Total impurities:1.0% max | |
| Assay | 98.0% to 101.0% |
| Residual solvents | Ethanol:1000ppm max |
| DMF:200ppm max | |
| Micro limits | Total aerobic microbial count-LT 1000 cfu/g |
| Yeast and Mold combined-LT 100 cfu/g | |
| E.coli--Absence | |
| Pathogenic Organizing--Absence |
| Index Name | Specifications |
| Appearance | White crystalline powder |
| Identification | According to IR |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.1% max |
| Melting point | 136 to 140degC |
| Heavy metals | 20ppm max |
| Related substance | Any single impurity:0.5% max |
| Total impurities:1.0% max | |
| Assay | 98.0% to 101.0% |
| Residual solvents | Ethanol:1000ppm max |
| DMF:200ppm max | |
| Micro limits | Total aerobic microbial count-LT 1000 cfu/g |
| Yeast and Mold combined-LT 100 cfu/g | |
| E.coli--Absence | |
| Pathogenic Organizing--Absence |