Shijiazhuang Dingmin pharmaceutical Sciences Co.,Ltd
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Model No.: 1618636-37-5
Brand: DM
Packaging: double PE with aluminium foil bag
Productivity: 100kg/month
Transportation: Ocean,Air
Place of Origin: Hebei,China
Supply Ability: 100kg/month
Certificate: ISO9001
Port: Shanghai
Payment Type: L/C,T/T,Paypal
Incoterm: FOB,CIF
CERTIFICATE OF ANALYSIS
| Product name | Ozanimod HCl | CAS No. | 1618636-37-5 | ||
| 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 | ||||
| Batch No. | DMOD202008001 | According to | Enterprise Standard | ||
| Mfg. date | 2020.08.20 | Test date | 2020.08.23 | ||
| Report date | 2020.08.23 | Retest date | 2022.08.19 | ||
| Items | Specification | Results | |||
| Description | White to off-white powder | Conform | |||
| Identification (RT by HPLC) | Conform with CRS | Conform | |||
| Melting point | 235.0~240.0°C | 235.5~236.0°C | |||
| Loss on drying | Not more than 1.0% | 0.18% | |||
| Residue on ignition | Not more than 0.5% | 0.05% | |||
| Heavy metals | Not more than 20ppm | Conform | |||
| 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% | |||
| Related chiral substance R-Enantiomer |
≤0.10% |
N.D. | |||
| Assay | 98.0~102.0% | 100.1% | |||
| Polymorphic form | Report data | Same as originator (2θ: 4.0, 8.0, 12.0, 13.8, 20.1, 21.1, 24.4, 26.2) | |||
| Solubility | Report data | Sparely soluble in water, methanol, ethanol. | |||
| Particle size | Report data | D(90): 240μm; D(95): 350μm | |||
| Storage | Sealed and stored in a dry place at room temperature. | ||||
| Conclusion: Complies with standard | |||||
Product Categories : APIs And Intermediates > APIs Powder
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