Shijiazhuang Dingmin pharmaceutical Sciences Co.,Ltd
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Modelo: 1618636-37-5
Marca: Dm
Paquete: PE doble con bolsa de papel de aluminio.
productividad: 100kg/month
transporte: Ocean,Air
Lugar de origen: Hebei, China
Apoyo sobre: 100kg/month
Certificados : ISO9001
Hafen: Shanghai
Tipo de Pago: L/C,T/T,Paypal
Incoterm: FOB,CIF
CERTIFICADO DE ANÁLISIS
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Product name |
Ozanimod HCl |
CAS No. |
1618636-37-5 |
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Chemical name |
(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride |
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Batch No. |
DMOD202008001 |
According to |
Enterprise Standard |
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Mfg. date |
2020.08.20 |
Test date |
2020.08.23 |
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Report date |
2020.08.23 |
Retest date |
2022.08.19 |
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Items |
Specification |
Results |
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Description |
White to off-white powder |
Conform |
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Identification (RT by HPLC) |
Conform with CRS |
Conform |
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Melting point |
235.0~240.0°C |
235.5~236.0°C |
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Loss on drying |
Not more than 1.0% |
0.18% |
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Residue on ignition |
Not more than 0.5% |
0.05% |
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Heavy metals |
Not more than 20ppm |
Conform |
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Related substances IMP-I IMP-II Any other single impurity Total impurities |
≤0.10% ≤0.10% ≤0.10% ≤0.5% |
N.D. 0.04 0.02% 0.16% |
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Related chiral substance R-Enantiomer |
≤0.10% |
N.D. |
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Assay |
98.0~102.0% |
100.1% |
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Polymorphic form |
Report data |
Same as originator (2θ: 4.0, 8.0, 12.0, 13.8, 20.1, 21.1, 24.4, 26.2) |
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Solubility |
Report data |
Sparely soluble in water, methanol, ethanol. |
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Particle size |
Report data |
D(90): 240μm; D(95): 350μm |
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Storage |
Sealed and stored in a dry place at room temperature. |
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Conclusion: Complies with standard |
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PRODUCTOS POR GRUPO : API e intermedios > APIS en polvo
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