Powder: | Yes |
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Certification: | GMP |
Suitable for: | Adult |
State: | Solid |
Purity: | >99% |
Transport Package: | Aluminum Foil Bag and Cardboard Bucket |
Customization: |
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Batch No. | HF170922 | Quantity | 32.2kgs |
Mfg. Date | Sep. 22, 2017 | Package | As required |
Rep. Date | Sep. 25, 2017 | Exp. Date | Sep. 21, 2019 |
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% | 4.44% | |
Heavy Metals | ≤20ppm | Complies | |
Residual Solvents | Isopropyl Acetate: ≤5000ppm | 20ppm | |
Acetone: ≤5000ppm | 32ppm | ||
Isopropanol: ≤5000ppm | 110ppm | ||
Related Substance | Maximum single impurity: ≤0.10% | 0.01% | |
Total Impurities: ≤0.50% | 0.05% | ||
Stereoisomers | Maximum single impurity: ≤0.10% | 0.01% | |
Total Impurities: ≤0.50% | 0.05% | ||
Assay (on the anhydrous basis) |
Valsartan: 49.0%~53.0% | 51.7% | |
Sacubitril: 47.0%~51.0% | 48.4% | ||
LCZ696: 98.0%~102.0% | 99.92% | ||
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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