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CAS NO.282526-98-1
1(0-1)Kilogram
CERTIFICATE OF ANALYSIS
Cetilistat 282526-98-1
| 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) | |||||||||||
CONCLUSION: THE PRODUCT CONFORMS WITH USP38