Imatinib Mesylate
| Product Name: | Imatinib Mesylate |
| Product Formula: | C29H31N7O |
| Molecular Weight: | 589.70 |
| CAS Number: | 220127-57-1 |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Description | White to yellowish white powder | In-house |
| 2 | Identification by IR | To be concord with working standard | In-house |
| 3 | Solubility | Freely soluble in water and sparingly soluble in methanol | In-house |
| 4 | Melting Range | 220°C to 225°C | In-house |
| 5 | Moisture Content by KF | Not more than 0.5% | In-house |
| 6 | Heavy Metals | Not more than 20 ppm | In-house |
| 7 | Related substances by HPLC a) Individual Impurity b) Total Impurities |
Not more than 0.5% Not more than 1.0% |
In-house |
| 8 | Assay by HPLC (on anhydrous basis) | 99.0 to 101.0% | In-house |
Storage: Recommended to store in a well-closed container, protected from direct sunlight and moisture.
Retest Period: 2 years from the date of manufacture
