China High Purity Weight Loss Drug Powder Apis Cetilistat Supplier and Exporter and Manufacturer, Find details about China Apis, Pharmaceutical from High Purity Weight Loss Drug Powder Apis Cetilistat Supplier and Exporter and Manufacturer
Batch no. | :20161226 | Quantity | :50kgs | ||||||||
Manuf. date | : 2016/12/26 | Expiry date | : 2018/12/26 | ||||||||
ANALYSIS TEST | SPECIFICATIONS | RESULTS | |||||||||
Description | White or almost white crystalline powder | Conforms | |||||||||
Specific rotation | -48°~-51°(on the anhydrous, solvent -free basis ) | -49.3° | |||||||||
Identification | The result of HPLC is consistent to the reference one. | ||||||||||
The result of IR consistent to the reference one. | Conforms | ||||||||||
Water | ≤0.2% | 0.05% | |||||||||
Related substances | |||||||||||
Total impurity | ≤1.0% | 0.4% | |||||||||
Individual unidentified inpurity | ≤0.1% | 0.02% | |||||||||
Related compound A(by HPLC) | ≤0.2% | Conforms | |||||||||
Related compound B(by GC) | ≤0.05% | ND | |||||||||
Related compound C(by HPLC) | ≤0.05% | Conforms | |||||||||
Formylleucine | ≤0.2% | Conforms | |||||||||
open ring epimer | ≤0.2% | Conforms | |||||||||
D-leucine | ≤0.2% | Conforms | |||||||||
Related compound D(by HPLC) | ≤0.2% | Conforms | |||||||||
Open ring amide | ≤0.1% | Conforms | |||||||||
Related compound E(by HPLC) | ≤0.2% | 0.09% | |||||||||
Residual solvents | |||||||||||
Methylene chloride | ≤100ppm | 20ppm | |||||||||
N-Hexane | ≤1500ppm | 200ppm | |||||||||
methanol | ≤1000ppm | 30ppm | |||||||||
tetrahydrofuran | ≤720ppm | ND | |||||||||
Hexane technical | ≤2000ppm | 80ppm | |||||||||
components(except n-Hexane) | |||||||||||
Total of n-Hexane and Heane | ≤3000ppm | 280ppm | |||||||||
technical components | |||||||||||
Residyal on ignition | ≤0.1% | 0.08% | |||||||||
Heavy metal | ≤20ppm | Conforms | |||||||||
Assay | 98.0%~101.5%(on the anhydrous,solvent -free | 99.8% | |||||||||
basis) |