CAS number： 274693-27-5
Molecular formula： C23H28F2N6O4S
molecular weight： 522.574
Chemical structure：
| Items | Specification | Results | ||||||
| Appearance | A white or almost white to light pink crystalline powder | Light pink crystalline powder | ||||||
| Solubility | Freely soluble in methanol, practically insoluble in water. | Conform | ||||||
| Qotical rotation | -51 0 """"-54。 | -54。 | ||||||
| Identification | HPLC-RT should comply with the WS | Conform | ||||||
| IR spectrum should comply with the WS | Conform | |||||||
| Related substance | A | Impurity TCG-DGA: not more than 0.15% | 0.01% | |||||
| Impurity TCG-ISO: not more than 0.1 5% | N.D | |||||||
| Impurity TCG-ACE : not more than 0.15% | N .D | |||||||
| Impurity TCG-IPD : not more than 0.15% | N.D | |||||||
| Impurity TCG-DET: not more than 0.15% | 0.04% | |||||||
| Impurity TCG-HDR: not more than 0.15% | N.D | |||||||
| Impurity TCG心伍0: not more than 0.15% | N .D | |||||||
| Any other individual impurity: not more than 0.10% | 0.04% | |||||||
| B | Impurity TCG-CPA: not more than 8ppm | N.D | ||||||
| C | Impurity TCG-CSR: not more than 0.15% | N .D | ||||||
| Total impurity(A and B and C ): not more than 0.5% | 0.20% | |||||||
| Residue on ignition | Not more than 0.1 % | 0.00% | ||||||
| Loss on drying | Not more than 0.5% | 0.10% | ||||||
| Heavy metal | Not more than 20ppm | Less than 20ppm | ||||||
| Limit of chloride | Not more than 0.02% | Less than 0.02% | ||||||
| Residual solvent | Toluene: not more than 890ppm | 210ppm | ||||||
| Methanol: not more than 3000ppm | N.D | |||||||
| Acetone: not more than 5000ppm | N.D | |||||||
| Cyclohexane: not more than 3880ppm | N.D | |||||||
| Assay (As dry basis) | 98.0-102.0% | 100.30% | ||||||
