Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Product name | Agomelatine | Manufacture date | Jan.13.2025 |
Batch number | SW250113 | Analysis date | Jan.14.2025 |
Batch quantity | 300kg | Expiry date | Jan.13.2027 |
Analysis | Specification | Rusult |
Appearance | White to almost white crystalline powder | white crystalline powder |
Solubility | This product is soluble in DMF, ethanol,water. | 108.4-108.5°C |
UV | Has an absorption maximum at 230nm | Conforms |
IR | Corresponding to reference spectrum | Conforms |
HPLC | Should the retention time of the main peak of the reference solution |
Conforms |
Chloride | ≤0.01% | Conforms |
Single impurity | ≤0.5% | 0.049% |
Total impurity | ≤0.1% | 0.06% |
Impurities I | ≤0.1% | Not detected |
Impurities II | ≤0.1% | Not detected |
Nh | ≤0.029% | 0.0002% |
Ethanol | ≤0.5% | 0.1% |
DCM | ≤0.06% | Not detected |
4 Hydrofuran | ≤0.072% | Not detected |
CHCI3 | ≤0.006% | 0.001% |
Loss on drying | ≤0.5% | 0.002% |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metal | ≤20ppm | Conforms |
Assay | ≥99.0% | 99.52% |
Conclusion | Conform with specification |
Packing description: | Sealed export grade drum & double of sealed plastic bag |
Storage: | Store in cool & dry place not freeze., keep away from strong light and heat |
Shelf life: | 2 years when properly stored |
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