 |
| Menge: | |
|---|---|
DY157272
130693-82-2
C10H17ClN2O4S3
Dorzolomide hydrochloride
Index name | Specification |
|
| Appearance | White crystalline powder |
|
| Distinguish | ||
| High-performance liquid chromatograph HPLC | The retention time of test sample major peak complies to reference standard |
|
| IR - Infrared spectrometry | The retention time of test sample major peak complies to reference standard |
|
| Inspection | ||
| Water content | No more than 0.5% |
|
| Residue on ignition | No more tan 0.1% |
|
| Sulphate | No more than 0.02% |
|
| Chloride | No more than 0.05% |
|
| Related impurity | Total impurity no more than 0.5% |
|
| Single impurity no more than 0.1% |
| |
| Limit of dorzalamide HCl related compound “A” | No more than 0.5% |
|
| Ethyl acetate | No more than 5000PPM |
|
| Heavy metal | No more than 0.001% |
|
| Purity | No less than 99.0% |
|
Index name | Specification |
|
| Appearance | White crystalline powder |
|
| Distinguish | ||
| High-performance liquid chromatograph HPLC | The retention time of test sample major peak complies to reference standard |
|
| IR - Infrared spectrometry | The retention time of test sample major peak complies to reference standard |
|
| Inspection | ||
| Water content | No more than 0.5% |
|
| Residue on ignition | No more tan 0.1% |
|
| Sulphate | No more than 0.02% |
|
| Chloride | No more than 0.05% |
|
| Related impurity | Total impurity no more than 0.5% |
|
| Single impurity no more than 0.1% |
| |
| Limit of dorzalamide HCl related compound “A” | No more than 0.5% |
|
| Ethyl acetate | No more than 5000PPM |
|
| Heavy metal | No more than 0.001% |
|
| Purity | No less than 99.0% |
|