Description

Daclatasvir Impurity 1 is a specified impurity of the antiviral active pharmaceutical ingredient (API) Daclatasvir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Daclatasvir-based drug products. The availability of a well-characterized impurity standard is essential for compliance with stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Daclatasvir API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Daclatasvir meets pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Daclatasvir synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Daclatasvir Impurity 1
CAS No.	100146-16-5
Molecular Formula	C40H50N8O6
Molecular Weight	738.88 g/mol
Synonyms	Daclatasvir Related Compound 1; BMS-790052 Impurity 1; (1R,3S,5R)-2-[(2S)-2-[[5-[4-[4-[2-[(2S)-1-[(2S)-2-[(Methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1H-imidazol-2-yl]pyrrolidin-1-yl]-2-oxoethyl]-2-azabicyclo[3.1.0]hexane-3-carboxylic Acid; Daclatasvir EP Impurity B; Daclatasvir USP Impurity 1
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS) to ensure identity and purity. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment. Our quality standards are designed to support compliance with ICH Q3A/B guidelines and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.