Description

Daclatasvir Dihydrochloride is a high-purity active pharmaceutical ingredient (API) and key intermediate in antiviral drug synthesis. This compound is critically important for the research, development, and commercial production of direct-acting antiviral (DAA) therapies targeting hepatitis C virus (HCV) infection. It is primarily required by pharmaceutical manufacturers, biotechnology research firms, and advanced contract development and manufacturing organizations (CDMOs) engaged in antiviral drug formulation.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of finished dosage forms targeting Hepatitis C Virus (HCV).
• Reference Standard in analytical laboratories for method development, validation, and quality control testing.
• Biochemical Research for studying the mechanism of action of NS5A inhibitors and viral replication.
• Pharmaceutical Intermediates in the synthesis of more complex antiviral drug candidates and prodrugs.
• Process Development for scaling up manufacturing processes under current Good Manufacturing Practices (cGMP).
• Regulatory Submissions, providing high-quality material for stability studies and regulatory filing packages (e.g., DMF, CMC sections).

Basic Information

Product Name	Daclatasvir Dihydrochloride
CAS No.	1009119-65-6
Molecular Formula	C40H50N8O6 · 2HCl
Molecular Weight	795.80 g/mol (Free base: 738.90)
Synonyms	Daclatasvir HCl; BMS-790052 Dihydrochloride; (1R,2S,5S)-N-[(1S)-1-Cyclopropyl-2-[(2S)-2-[[5-[(2R,5R)-1-[(2S)-2-[[(2S)-1-[(2S)-2-[(methoxycarbonyl)amino]-3-methyl-1-oxobutyl]-2-pyrrolidinyl]methyl]-2-oxo-1,5-diazocan-5-yl]-3-methyl-2-oxo-1-pyrrolidinyl]-2H-imidazo[4,5-c]pyridin-2-yl]-1H-imidazol-5-yl]-2-oxoethyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide Dihydrochloride; Daklinza (Brand Name) API; NS5A Inhibitor Dihydrochloride
EINECS	Contact for details

Quality Control

Our Daclatasvir Dihydrochloride is manufactured and tested to meet stringent quality standards appropriate for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant quality management systems, and material can be supplied under current Good Manufacturing Practice (cGMP) conditions for advanced clinical and commercial use. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.2%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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