- Product Details
Keywords
- Ledipasvir
- 1256388-51-8
- GS-5885
Quick Details
- ProName: Ledipasvir
- CasNo: 1256388-51-8
- Molecular Formula: C49H54F2N8O6
- Appearance: Light yellow powder
- Application: Pharmaceutical intermediates
- DeliveryTime: With three or five working days
- PackAge: 25kg/fiber drum, sealed package
- Port: China main port
- ProductionCapacity: 10 Metric Ton/Month
- Purity: 99.3%
- Storage: Seald package, keep away from light
- Transportation: Sealed package, keep away from light
- LimitNum: 1 Metric Ton
- Valid Period: 2019-12-18
Superiority
1. Advanced facility and Equipment
2. Competent technical team
3 .Strong R & D support
4,high quality products with high stability
5, Competitive price
5.Customer tailored service
Details
Ledipasvir (formerly GS-5885) is an experimental drug for the treatment of hepatitis C being developed by Gilead Sciences.[1] It is currently in Phase III clinical trials.[2] It is being studied in combination with other direct-acting antiviral agents that interfere with HCV replication.
Ledipasvir is an inhibitor of the hepatitis C virus HCV NS5A protein.
Ledipasvir is being tested in interferon-free regimens with other direct-acting antiviral agents for hepatitis C.
Data presented at the 20th Conference on Retroviruses and Opportunistic Infections in March 2013 showed that a triple regimen of the nucleotide analogue inhibitor sofosbuvir, ledipasvir, and ribavirin produced a 12-week post-treatment sustained virological response (SVR12) rate of 100% for both treatment-naive patients and prior non-responders with HCV genotype 1.[3][4] Gilead is developing a sofosbuvir + ledipasvir coformulation that is being tested with and without ribavirin.
Specification
Test
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Specification
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Result
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Appearance
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White to tinted(tan, yellow or pink) powder
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Light yellow powder
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Identification
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IR: The IR absorption spectrum of the sample must be concordant with standard substance.
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Conforms
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HPLC: The HPLC spectrum of the sample must be concordant with the standard substance.
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Conforms
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Water
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NMT 0.5%
|
0.26%
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Residue On Ignition
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NMT 0.1%
|
0.07%
|
Heavy Metals
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NMT 20ppm
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Conforms
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Acetone Content
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5.1%~7.1%
|
6.8%
|
Residual Solvents
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Acetonitrile: NMT 0.041%
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N.D.
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Ethyl Acetate: NMT 0.5%
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N.D.
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|
Related Substances
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Any other impurity: NMT 0.3%
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0.16%
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Total impurities: NMT 1.0%
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0.23%
|
|
Assay(On anhydrous and solvent free dry basis)
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98.0%~102.0%
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99.72%
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Storage
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Store in a tightly closed container in a cool and dry place, below 20℃.
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|
Conclusion
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Confirm to enterprise standard
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