China High Purity Pharmaceuticals Chemical Apis Trelagliptin Succinate 1029877-94-8/Manufacturer and Supplier and Exporter, Find details about China Trelagliptin Succinate, 1029877-94-8 from High Purity Pharmaceuticals Chemical Apis Trelagliptin Succinate 1029877-94-8/Manufacturer and Supplier and Exporter
Batch No. | HF171206 | Quantity | 40kgs |
Mfg. Date | Dec. 06, 2017 | Package | As required |
Rep. Date | Dec. 09, 2017 | Exp. Date | Dec. 05, 2019 |
Items | Standards | Results | |
Appearance | White to off-white powder | White powder | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Sparingly soluble in methanol and soluble in water | Complies | |
Water Content(KF) | ≤ 1.00% | 0.12% | |
Residue on Ignition | ≤ 0.10% | 0.06% | |
Heavy Metals | ≤ 10ppm | Complies | |
Specific Rotation | +13º~+18º | +15º | |
Enantiomers | ≤ 0.50% | ND | |
Residual Solvents | Methanol: ≤3000ppm | ND | |
Dichloromethane: ≤600ppm | ND | ||
Tetrahydrofuran: ≤720ppm | ND | ||
Acetonitrile: ≤410ppm | ND | ||
Isopropanol: ≤5000ppm | ND | ||
Related Substances | Maximum single impurity: ≤0.10% | 0.06% | |
Total impurities: ≤0.50% | 0.17% | ||
Assay | 98.0%~102.0% | 99.87% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage Condition | Preserve in tight,light-resistant containers, stored at room temperature(about 20ºC) and protect from light |