Customization: | Available |
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Function: | Pharmaceutical Medicine |
Certification: | GMP, FDA, ISO |
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Audited by an independent third-party inspection agency
Items | Standards | Results |
Appearance | White or off-white solid powder | Complies |
Identification | By IR | Complies |
By HPLC | Complies | |
Water Content(KF) | 4.0%~6.0% | 4.50% |
Heavy Metals | ≤20ppm | Complies |
Residual Solvents | Isopropyl Acetate: ≤5000ppm | ND |
Acetone: ≤5000ppm | 98ppm | |
Isopropanol: ≤5000ppm | 50ppm | |
Related Substance | Maximum single impurity: ≤0.10% | 0.06% |
Total Impurities: ≤0.50% | 0.11% | |
Stereoisomers | Maximum single impurity: ≤0.10% | ND |
Total Impurities: ≤0.50% | ND | |
Assay (on the anhydrous basis) |
Valsartan: 49.0%~53.0% | 51.2% |
Sacubitril: 47.0%~51.0% | 48.8% | |
LCZ696: 98.0%~102.0% | 99.85% | |
Reference Standard | In-house Standard | |
Conclusion | The product complied to In-house standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |