China 99% Assay High Purity Roflumilast Pharmaceutical Chemical Powder with CAS 162401-32-3, Find details about China API Roflumilast, Pharmaceutical from 99% Assay High Purity Roflumilast Pharmaceutical Chemical Powder with CAS 162401-32-3
Batch No. | HF170515 | Quantity | 15.6kgs |
Mfg. Date | May. 15, 2017 | Package | As required |
Rep. Date | May. 18, 2017 | Exp. Date | May. 14, 2019 |
Items | Standards | Results | |
Appearance | White or off-white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Highly soluble in methanol,soluble in ethanol,acetonitrile; slightly soluble in water | Complies | |
Melting Point | 156ºC~160ºC | 157.6ºC~158.5ºC | |
Water Content | ≤ 0.50% | 0.25% | |
Residue on Ignition | ≤ 0.10% | 0.05% | |
Heavy Metal | ≤10ppm | Complies | |
Residual Solvents | Dichloromethane: ≤100ppm | ND | |
Hexane: ≤200ppm | ND | ||
Ethyl acetate: ≤500ppm | ND | ||
Tetrahydrofuran: ≤100ppm | ND | ||
Related Substances | Impurity A: ≤0.10% | 0.07% | |
Impurity B: ≤0.10% | 0.08% | ||
Any other single impurity: ≤0.10% | 0.08% | ||
Total Impurities: ≤0.50% | 0.15% | ||
Assay (HPLC basis on drying) | 98.0%~102.0% | 99.99% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |