Description

Ledipasvir is a high-purity, direct-acting antiviral agent (DAA) and a key pharmaceutical intermediate. It is a critical component in combination therapies for the treatment of chronic hepatitis C virus (HCV) infection, specifically targeting the HCV NS5A protein. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of advanced antiviral medications. Ledipasvir CAS NO 1256388-51-8 is supplied under stringent quality controls to meet the exacting standards of the global pharmaceutical industry.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the NS5A inhibitor component in fixed-dose combination drugs for Hepatitis C treatment.
• Pharmaceutical R&D: Serves as a critical reference standard and building block in the research and development of new antiviral therapies and combination regimens.
• Generic Drug Manufacturing: A vital raw material for companies producing generic versions of leading HCV therapies after patent expiry.
• Clinical Trial Material: Used in the formulation of drugs for Phase I-IV clinical studies investigating HCV treatment protocols.
• Biochemical Research: Employed in virology and molecular biology studies to understand HCV replication mechanisms and resistance profiles.

Basic Information

Product Name	Ledipasvir
CAS No.	1256388-51-8
Molecular Formula	C49H54F2N8O6
Molecular Weight	889.00 g/mol
Synonyms	GS-5885; GS 5885; Ledipasvirum; 2,2'-[[(2S,5S)-1-[4-[9,9-Difluoro-7-[2-[(1R,3S,4S)-2-[(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-2-azabicyclo[2.2.1]hept-3-yl]-1H-benzimidazol-6-yl]-9H-fluoren-2-yl]-1H-imidazol-2-yl]-1-pyrrolidinyl]carbonyl]bis(azanediyl)]bis[3-methylbutanoic acid] dimethyl ester; NS5A Inhibitor GS-5885
EINECS	Contact for details

Quality Control

Our Ledipasvir is manufactured and tested to meet the rigorous standards required for pharmaceutical intermediates. Quality is assured through a comprehensive battery of analytical tests including HPLC for purity, residual solvent analysis, and identification via spectroscopic methods. We adhere to cGMP principles where applicable, and a detailed Certificate of Analysis (COA) is provided with each batch, documenting compliance with agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.