China Manufacturer Supply Ledipasvir Compd with Acetone Pharmaceutical Powder Chemical API, Find details about China API Ledipasvir Compd with, Pharmaceutical Ledipasvir Compd with from China Manufacturer Supply Ledipasvir Compd with Acetone Pharmaceutical Powder Chemical API
Batch No. | HF160715 | Quantity | 30kgs |
Mfg. Date | Jul. 15, 2016 | Package | As required |
Rep. Date | Jul. 18, 2016 | Exp. Date | Jul. 14, 2018 |
Items | Standards | Results | |
Appearance | White or off-white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Melting Point | 170.0ºC~225.0ºC | 180.0ºC~193.5ºC | |
Water Content | ≤1.00% | 0.30% | |
Residue On Ignition | ≤0.10% | 0.05% | |
Heavy Metal | ≤20ppm | Complies | |
Enantisomer | ≤0.10% | ND | |
Residual Solvent | Isopropyl Acetate: ≤5000ppm | ND | |
Ethyl Acetate: ≤5000ppm | 98ppm | ||
Acetone: ≤66324ppm | 60000ppm | ||
N,N-Dimethyl formamide: ≤880ppm | ND | ||
1,4-Dioxane: ≤380ppm | ND | ||
Ethanol: ≤5000ppm | ND | ||
1,2-Dimethoxyethane:≤100ppm | ND | ||
Related Substances | The max single impurity ≤0.50% | Complies | |
The total impurities ≤1.00% | 0.32% | ||
Assay | ≥99.0% | 99.88% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |