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% |