CAS No:202138-50-9
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Appearance | White or off-white,crystalline ppowder |
| Solubility | Soluble in methanol,slightly in water,practically insoluble in isopropyl ether. |
| Identification | IR:The infrared absorption spectrum of the sample should correspond to the spectrum of the reference substance. |
| HPLC:The retention time of the major peak of the sample solution corresponds to that of the reference solution,as obtained in the Assay. | |
| Specific optical rotation,on anhydrous substance | -15°~-20° |
| Water | ≤1.0% |
| Residue on ignition | ≤0.2% |
| Heavy metals | ≤20ppm |
| Assay,on anhydrous substance | 98.0%~102.0% |
| Related substances | Impurity A≤0.0005% |
| Impurity B≤0.15% | |
| Impurity C≤0.15% | |
| Impurity D≤0.15% | |
| Impurity E≤0.5% | |
| Impurity F≤0.15% | |
| Impurity G≤0.15% | |
| Impurity H≤0.15% | |
| Impurity I≤0.15% | |
| Impurity J≤0.15% | |
| Single unspecified impurity≤0.10% | |
| Total impurities≤1.0% | |
| Isomer | ≤0.5% |
| Fumaric acid,on anhydrous substance | 17.7%~18.8% |
| Residual solvents | Isopropyl alcohol:≤5000ppm |
| Isopropyl ether:≤300ppm | |
| Microbial limits | Total aerobicmicrobial count:≤1000cfu/g |
| Total molds and yeasts count:≤100cfu/g | |
| Escherichia coli:Absent(1g） |