| Customization: | Available |
|---|---|
| Certification: | GMP, FDA |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Appearance | White or off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Loss on Drying | ≤ 1.00% | 0.30% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.05% |
| Isomer | ≤ 0.10% | 0.05% |
| Residual Solvents | Acetonitrile: ≤4100ppm | 100ppm |
| Tetrahydrofuran: ≤720ppm | 50ppm | |
| Ethyl Acetate: ≤5000ppm | 1000ppm | |
| Isopropanol: ≤5000ppm | 2000ppm | |
| Relative Substance | Any single impurity: ≤0.20% | 0.12% |
| Total Impurities: ≤0.50% | 0.25% | |
| Assay (on the anhydrous basis) | 97.0%~103.0% | 99.30% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
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