Audited Supplier
Tofacitinib Citrate
Anti-Rheumatism
GMP, FDA, ISO
Medicine Grade
Chemicals
Solid
Not Volatile
White or off-White Solid Powder
Sjar-Tech
Cardboard Drums or Cartons
gram, kilogram
China
2934999099
Product Description
| Items | Standards | Results |
| Appearance | White or off-white solid powder | White solid powder |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Slightly soluble in water, very slightly soluble in methanol, hardly insoluble in ethanol, acetone and acetonitrile | Complies |
| Loss on Drying | ≤ 0.50% | 0.32% |
| Heavy Metal | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.20% | 0.05% |
| Enantiomer | (SS) ≤0.1% | ND |
| Citrate | 36.2% ~ 40.0% (on dried basis) | 37.3% |
| Residual Solvents | Petroleum ether: ≤3000ppm | ND |
| Ethanol: ≤5000ppm | 260ppm | |
| Ethyl ether: ≤5000ppm | ND | |
| Acetone: ≤5000ppm | ND | |
| n-Butyl alcohol: ≤5000ppm | ND | |
| Dichloromethane: ≤600ppm | ND | |
| Related Substances | (RS+SR): ≤0.10% | ND |
| Any single impurity: ≤0.10% | 0.07% | |
| Total Impurities: ≤0.30% | 0.21% | |
| Assay (HPLC basis on drying) | 99.0%~101.0% | 99.85% |
| Particle Size | D90: ≤50µm | 27.61µm |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
