| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| 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% | |||||||||
| Heavy metal | ≤20ppm | Conforms | |||||||||
| Assay | 98.0%~101.5%(on the anhydrous,solvent -free | 99.8% | |||||||||
| basis) | |||||||||||
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