Description

Daclatasvir is a potent and highly selective non-structural protein 5A (NS5A) inhibitor, a key component in antiviral therapy. Its primary value lies in its critical role in the treatment of chronic hepatitis C virus (HCV) infection, particularly genotype 3. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing direct-acting antiviral (DAA) combination therapies to achieve high cure rates.

Application

• Pharmaceutical API: Core active ingredient in the formulation of antiviral tablets for the treatment of Hepatitis C Virus (HCV).
• Combination Therapy: Used in fixed-dose combination products, most notably with sofosbuvir, for pan-genotypic HCV treatment regimens.
• Clinical Research: Serves as a reference standard and key material in virology research and the development of new antiviral protocols.
• Generic Drug Manufacturing: Critical for companies producing bioequivalent versions of branded HCV therapeutics.
• Preclinical Studies: Utilized in pharmacological and toxicological studies to assess drug efficacy and safety profiles.

Basic Information

Product Name	Daclatasvir
CAS No.	1009119-64-5
Molecular Formula	C40H50N8O6
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir dihydrochloride (common salt form); BMS-790052; Daklinza (Brand Name); N,N'-[[1,1'-Biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis[carbamic acid] C,C'-dimethyl ester; HCV NS5A Inhibitor; NS5A replication complex inhibitor
EINECS	Contact for details

Quality Control

Our Daclatasvir is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with typical purity levels ≥98.5% (by HPLC). A comprehensive Certificate of Analysis (COA) is provided for every shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We adhere to cGMP guidelines to ensure consistency, traceability, and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and potency. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤1.5%
Any single unknown impurity	≤0.10%
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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