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Incoterm: | FOB,CIF |
Min. Order: | 25 Kilogram |
Delivery Time: | 5 Days |
Model No.: cy540737-29-9
Certificate of Analysis
Product Name: Tofacitinib Citrate
Pharmaceutical Intermediate CAS No.: 540737-29-9
Batch No. | HF161021 | Quantity | 3.66kgs |
Mfg. Date | Oct. 21, 2016 | Package | As required |
Rep. Date | Oct. 23, 2016 | Exp. Date | Oct. 20, 2018 |
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 | |
Specific Rotation | +9.0°~ +13.0°(0.6g/100ml in DMSO) | +10.0° | |
Loss on Drying | ≤ 0.50% | 0.25% | |
Heavy Metal | ≤ 10ppm | Complies | |
Residue on Ignition | ≤ 0.20% | 0.10% | |
Enantiomer | (SS) ≤0.1% | ND | |
Citrate | 36.2% ~ 40.0% (on dried basis) | 38.3% | |
Residual Solvents | Petroleum ether: ≤3000ppm | ND | |
Ethanol: ≤5000ppm | ND | ||
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% | 0.05% | ||
Total Impurities: ≤0.30% | 0.07% | ||
Assay | 99.0%~101.0% | 99.85% | |
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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Product Categories : Organic Intermediate > Pharmaceutical Intermediates