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Betrixaban maleate coa
1. SHANDONG OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-15589503653 FAX:0086-0535-6715688
Address: Rm 528, Building 2, No. 300-2, Changjiang Rd, YEDA, YanTai City, ShanDong
Province, China sales@octagonchem.com
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Product name Betrixaban Maleate (Cas 936539-80-9)
Batch No. 20201113 Mfg. Date 2020.11.13
Rep. Date 2020.11.18 Exp. Date 2022.11.12
Packing 1kg/tin Batch Quantity 3.2KG
Test Items Standards: Enterprise Results
Appearance Off-white to light yellow powder conforms
Identification HPLC/1HNMR Conforms
Solubility
Very soluble in ethanol, slightly soluble
in water
Conforms
Melting point 200~202°C 201.2°C
Residue on ignition NMT0.5% 0.09%
Content of maleate 18.5%~22.5% 20.59%
Water NMT1.0% 0.32%
Heavy metals NMT20ppm <20ppm
Related substances
Single impurity: NMT0.5%
Total impurities: NMT1.0%
0.20%
0.49%
Purity (HPLC) NLT99.0% 99.51%
Assay 98.0%~102.0% 99.36%
Conclusion It meets the requirements of Enterprise Standards
Storage Store in a well-closed container at ambient temperature
Prepared by: LI Reviewed by: WEI Released by:Zhang