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 |
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