 |
| Cantidad: | |
|---|---|
DY12294
154598-52-4
C14H9ClF3NO2
Efavirenz
| Index Name | Specifications |
| Appearance | White to off-white powder |
| Solubility | Practically insoluble in water ,freely soluble in methanol and dichloromethane |
| Specific rotation at 25degC | -91 to -97 degree |
| Identification | UV IR HPLC |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.2% max |
| Heavy metal | 0.002% max |
| Limit of Efavirenz Enantiomer | 0.1% max |
| Related substance | Impurity A: 0.15% max Impurity B: 0.15% max Other sigle impurity 0.1% max Total impurity 1.0% max |
| Residual solvents | Tert-Butylmethyl ether : 0.5% max Ethanol: 0.1% max Toluene: 0.089% max N-hexane: 0.029% max |
| Assay | 98.0 to 102.0% |
| Index Name | Specifications |
| Appearance | White to off-white powder |
| Solubility | Practically insoluble in water ,freely soluble in methanol and dichloromethane |
| Specific rotation at 25degC | -91 to -97 degree |
| Identification | UV IR HPLC |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.2% max |
| Heavy metal | 0.002% max |
| Limit of Efavirenz Enantiomer | 0.1% max |
| Related substance | Impurity A: 0.15% max Impurity B: 0.15% max Other sigle impurity 0.1% max Total impurity 1.0% max |
| Residual solvents | Tert-Butylmethyl ether : 0.5% max Ethanol: 0.1% max Toluene: 0.089% max N-hexane: 0.029% max |
| Assay | 98.0 to 102.0% |