Complaint
Name | Ledipasvir |
Synonyms | GS 588 |
Brand | Zebrago |
Molecular Formula | C49H54F2N8O6 |
Molecular Weight | 889.00 |
CAS NO | 1256388-51-8 |
Ledipasvir is a direct acting antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). After completing Phase III clinical trials, on February 10, 2014 Gilead filed for U.S. approval of a ledipasvir/sofosbuvir fixed-dose combination tablet for genotype 1 hepatitis C.The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without PEG-interferon or ribavirin.
Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion, a hepatitis C virus protein.
Ledipasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, ledipasvir is indicated for the treatment of HCV genotypes 1, 4, 5, and 6. Its use has also proven successful in the treatment of HCV in patients co-infected with HIV.
Certificate of Analysis
| Batch Number | Z20190412001 | ||
| Production Date | 2019.04.12 | ||
| Batch Quantity | 80 KGS | ||
| Item | Test Standard | Testing Result | |
| Appearance | Powder | Complies | |
| Color | White fine Powder | Complies | |
| Particle Size | 100% pass 80 mesh | Complies | |
| Oder | Characteristic | Complies | |
| Taste | Characteristic | Complies | |
| Loss on Drying | ≤5.0% | 2.20% | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Residual acetone | ≤0.1% | Complies | |
| Residual Ethanol | ≤0.5% | Complies | |
| Heave Mentals | ≤10ppm | Complies | |
| Na | ≤0.1% | <0.1% | |
| Pb | ≤3 ppm | Complies | |
| Total Plate | <1000CFU/g | Complies | |
| Yeast & Mold | <100 CFU /g | Complies | |
| E. Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
| Conclusion: Conform with USP Standard | |||
Storage:Closed container. dry & cool. keep away from moisture &strong light
Shelf life:24 Months
Shipping Options as follows
| EMS | Around 7-10 working days |
| DHL | Around 3-5 working days |
| Fedex | Around 4-6 working days |
| TNT | Around 6-7 working days |
| By Air | Around 5-7 working days |
| By Sea | Around 15-30 working days |
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