Tofacitinib Citrate 540737
Tofacitinib Citrate 540737
Description
Basic Info.
Model NO. | Tofacitinib Citrate |
Color | White or off-White Solid Powder |
Transport Package | Cardboard Drums or Cartons |
Specification | gram, kilogram |
Trademark | Sjar-Tech |
Origin | China |
HS Code | 2934999099 |
Production Capacity | 50kg/Month |
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 |
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