Description

Daclatasvir Impurity 7 (Rrrr-Isomer) is a stereochemically defined impurity of the antiviral drug Daclatasvir, used for the treatment of chronic hepatitis C virus (HCV) infection. This specific isomer is critical for pharmaceutical research and development, serving as a certified reference material for method development, validation, and quality control testing. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require high-purity impurities to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Daclatasvir drug substance and finished products.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor and control the levels of this specific isomer during API manufacturing to meet ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Daclatasvir to understand degradation pathways.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior of isomeric impurities.

Basic Information

Product Name	Daclatasvir Impurity 7 (Rrrr-Isomer)
CAS No.	1417333-58-4
Molecular Formula	C₄₀H₅₀N₈O₆
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir Related Compound Rrrr; BMS-790052 Impurity 7 (Rrrr-Isomer); (1R,2S,5R,7S,10R,11S,14R,15S,18R)-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]pyrrolidin-1-yl]-2-oxoethyl]hexahydro-1H-1,5-methanopyrido[1,2-a][1,5]diazocine-3-carboxamide; Daclatasvir EP Impurity R; Daclatasvir USP Impurity Rrrr; HCV NS5A Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity 7 (Rrrr-Isomer) is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC purity determination, structural confirmation (NMR, MS), and chiral purity assessment to ensure identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Our quality commitment aligns with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere in a desiccator.

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%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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