Description

Daclatasvir Impurity CAS NO 1417333-83-5 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Daclatasvir. This compound is critical for ensuring the safety and efficacy of antiviral drug formulations by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on hepatitis C virus (HCV) treatment development and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine testing in HPLC and LC-MS analysis.
• Drug Substance Characterization: Used in the structural elucidation and impurity profiling of Daclatasvir API batches to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed as a marker to monitor impurity formation in Daclatasvir drug products under various stress and storage conditions.
• Process Chemistry Optimization: Aids in identifying and tracking the source of impurities during the synthesis and purification of Daclatasvir, enabling process refinement.
• Quality Control Testing: Used in-house by API manufacturers and third-party testing laboratories to ensure batch-to-batch consistency and purity specifications.

Basic Information

Product Name	Daclatasvir Impurity
CAS No.	1417333-83-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Daclatasvir Related Compound; Daclatasvir Process Impurity; Daklinza Impurity; BMS-790052 Impurity; (1R,3S,5S)-N-[(1S)-1-Cyclopropyl-2-[(2S)-2-[[5-[(2R,5R)-1-[(2S)-2-[[(2S)-1-[(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]carbonyl]-2-pyrrolidinyl]-5-(4-pyridinyl)-1H-imidazol-2-yl]-1H-imidazol-2-yl]pyrrolidinyl]-2-oxoethyl]-2-azabicyclo[3.1.0]hexane-3-carboxamide (Impurity); HCV NS5A Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. 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 (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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