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| Lansoprazole Hydroxy | CAS 253345-80-1 | |
|---|---|---|
| Test | Specification |  |
| Description | An off-white to cream colour crystalline powder. | |
| Identification by HPLC | The retention time of the major peak in the chromatogram of test solution should correspond to that of the standard solution | |
| Solubility | Soluble in methanol. | |
| Related substances by HPLC | ||
| 2,3-Dimethyl pyridine-1-oxide | Not more than 0.10% | |
| 2,3-Dimethyl-4-Nitro pyridine-1-oxide | Not more than 0.15% | |
| 2,3-Dimethyl-4-(2,2,2-trifluoroethoxy)pyridine-1-oxide | Not more than 0.15% | |
| 2-Acetyloxy methyl-3-methyl-4-(2,2,2-trifluoroethoxy)Pyridine | Not more than 1.50% | |
| Maximum single unknown Impurity | Not more than 0.50% | |
| Total Impurity | Not more than 4.00% | |
| Lansoprazole Hydroxy | |
|---|---|
| CAS 253345-80-1 | |
| |
|
| Test | Specification |
| Description | An off-white to cream colour crystalline powder. |
| Identification by HPLC | The retention time of the major peak in the chromatogram of test solution should correspond to that of the standard solution |
| Solubility | Soluble in methanol. |
| Related substances by HPLC | |
| 2,3-Dimethyl pyridine-1-oxide | Not more than 0.10% |
| 2,3-Dimethyl-4-Nitro pyridine-1-oxide | Not more than 0.15% |
| 2,3-Dimethyl-4-(2,2,2-trifluoroethoxy)pyridine-1-oxide | Not more than 0.15% |
| 2-Acetyloxy methyl-3-methyl-4-(2,2,2-trifluoroethoxy)Pyridine | Not more than 1.50% |
| Maximum single unknown Impurity | Not more than 0.50% |
| Total Impurity | Not more than 4.00% |
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