| Customization: | Available |
|---|---|
| CAS No.: | 145040-37-5 |
| Formula: | 145040-37-5 |
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| Package | carton drum with two plastic bags inside |
| Net weight | 25KG/Drum |
| Storage | Sealed in cool and dry place to avoid moisture and light |
| Shelf life | 2 years when properly stored |
| Lead time | 1~3 days after confirmation |
| Item | Specification | |
| Appearance | White to off-white powder | |
| Clarity and Color solution | Solution in chlorofor at 5% is clear and colourless | |
| The | 1.HPLC | The retention time of major peak in the chromatogram of the test solution corresponds to that of the standard solution, as obtained in the procedure for prganic impurities by HPLC |
| 2. IR | Similar to standard | |
| Water | Not more than 0.30% | |
| Residue on Ignition | Not more than 0.1% | |
| Tin | NMT 10ppm | |
| Azide by IC | NMT 10ppm | |
| Melting range | 160ºC~166ºC | |
| Heavy Metals | Not more than 10 ppm | |
| As | < 1 ppm | |
| Particle size distribution | 90% <30 µm 50% ≤10 µm |
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| Organic impurities by HPLC | Ethyl Candesartan -NMT 0.15% Desethyl Candesartan -NMT 0.15% N2-Ethyl Candesartan Cilexei -NMT 0.15% Any unknown impurity -NMT 0.10% Total impurities -NMT 0.60% |
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| Assay by potentiometry | Not less than 99.0% - 101.0% on dried basis | |
| OVI (organic volatile impurity) |
Methano -NMT 0.3% Ethanol -NMT 0.5% Diethyl ether -NMT 0.5% Aceton -NMT 0.5% Dichloromethan -NMT 0.06% Dimethylformamide -NMT 0.088% |
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Microbiological Contarnination/g |
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| NEMA&NDEA | 0.3ppm&0.18ppm | |
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