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| Lansoprazole Chloro | CAS 127337-60-4 | |
|---|---|---|
| Test | Specification |  |
| Description | An white to off-white colour powder | |
| Identification by A) HPLC | The retention time of the major peak in the chromatogram of test solution should correspond to that of the standard solution | |
| B) IR | The Infra-red absorption spectrum of the sample should exhibit maxima only at the same wavelengths as that of a similar preparation of working standard | |
| Solubility | Soluble in Methanol | |
| Moisture Content | Not more than 1.0 %w/w | |
| Related substances by HPLC | ||
| 2-Acetyloxy methyl-3-methyl-4-(2,2,2-trifluoroethoxy)Pyridine | Not more than 0.50% | |
| 2-(Hydroxy methyl)-3-methyl-4-(2,2,2-trifluoroxy)Pyridine Hydrochloride | Not more than 0.50% | |
| Any other single unknown Impurity | Not more than 0.50% | |
| Total Impurity | Not more than 1.00% | |
| Assay (on anhydrous basis) | Not less than 98.0% and Not more than 102.0%w/w | |
| Lansoprazole Chloro | |
|---|---|
| CAS 127337-60-4 | |
| |
|
| Test | Specification |
| Description | An white to off-white colour powder |
| Identification by A) HPLC | The retention time of the major peak in the chromatogram of test solution should correspond to that of the standard solution |
| B) IR | The Infra-red absorption spectrum of the sample should exhibit maxima only at the same wavelengths as that of a similar preparation of working standard |
| Solubility | Soluble in Methanol |
| Moisture Content | Not more than 1.0 %w/w |
| Related substances by HPLC | |
| 2-Acetyloxy methyl-3-methyl-4-(2,2,2-trifluoroethoxy)Pyridine | Not more than 0.50% |
| 2-(Hydroxy methyl)-3-methyl-4-(2,2,2-trifluoroxy)Pyridine Hydrochloride | Not more than 0.50% |
| Any other single unknown Impurity | Not more than 0.50% |
| Total Impurity | Not more than 1.00% |
| Assay (on anhydrous basis) | Not less than 98.0% and Not more than 102.0%w/w |
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