Description

Daclatasvir Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Daclatasvir, a key medication for treating Hepatitis C. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Daclatasvir API.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of Daclatasvir and related antiviral compounds.
• Employed as a system suitability standard in pharmacopeial testing to ensure analytical instrument performance.

Basic Information

Product Name	Daclatasvir Impurity 20
CAS No.	1312335-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Daclatasvir Related Compound 20; Daklinza Impurity 20; BMS-790052 Impurity 20; (1R,3S,5S)-N-[(1S)-1-Cyclopropyl-2-[(2S)-2-[[5-[(2R,5R)-1-(2-methylpropanoyl)-5-(4-pyridinyl)-1,2,4-triazol-3-yl]-1,3-thiazol-2-yl]amino]-1-oxo-3,3-dimethyl-4-penten-2-yl]amino]-2-oxoethyl]-3-azabicyclo[3.1.0]hexane-6-carboxamide; Daclatasvir Process Impurity
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity 20 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory documentation.

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 material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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