China Made Vildagliptin Powder Pharmaceutical Chemicals CAS 274901-16-5, Find details about China Vildagliptin, 274901-16-5 from China Made Vildagliptin Powder Pharmaceutical Chemicals CAS 274901-16-5
Batch No. | HF170108 | Quantity | 228.5kgs |
Mfg. Date | Jan. 08, 2017 | Package | As required |
Rep. Date | Jan. 11, 2017 | Exp. Date | Jan. 07, 2019 |
Items | Standards | Results | |
Appearance | White to off-white crystalline powder | White crystalline powder | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Water Content(KF) | ≤ 1.00% | 0.08% | |
Melting Point | 148.0ºC~150.0ºC | 148.7ºC~149.9ºC | |
Residue on Ignition | ≤ 0.10% | 0.07% | |
Heavy Metals | ≤ 20ppm | Complies | |
Sulphate | ≤ 0.02% | Complies | |
Chloride | ≤ 0.05% | Complies | |
Residual Solvents | Acetonitrile: ≤410ppm | ND | |
Dichloromethane: ≤600ppm | ND | ||
Isopropyl alcohol: ≤5000ppm | 960ppm | ||
Related Substances | Maximum single impurity: ≤0.20% | 0.09% | |
Total impurities: ≤1.00% | 0.15% | ||
EE(by HPLC) | ≥99.00% | 99.88% | |
Purity(by HPLC) | ≥99.00% | 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 |