Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Batch No. | HF170212 | Quantity | 30.5kgs |
Mfg. Date | Feb. 12, 2017 | Package | As required |
Rep. Date | Feb. 15, 2017 | Exp. Date | Feb. 11, 2019 |
Items | Standards | Results | |
Appearance | White or off-white powder, odorless | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Melting Point | 181.0ºC~185.0ºC | 183.0ºC~184.0ºC | |
Specific Rotation | +13°~+18° | +16.6° | |
Water Content(KF) | ≤ 0.50% | 0.07% | |
Residue on Ignition | ≤ 0.20% | 0.08% | |
Heavy Metals | ≤ 20ppm | Complies | |
Residual Solvents | Ethanol: ≤5000ppm | 700ppm | |
DMF: ≤880ppm | ND | ||
Dichloromethane: ≤600ppm | ND | ||
Toluene: ≤890ppm | ND | ||
Isopropyl alcohol: ≤5000ppm | ND | ||
Related Substances | Maximum single impurity: ≤0.10% | 0.04% | |
Total impurities: ≤1.00% | 0.12% | ||
Assay | 98.0%~102.0% | 99.94% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |