Description

Daclatasvir Impurity E is a specified impurity of the antiviral drug Daclatasvir, a key component in hepatitis C treatment regimens. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories and pharmaceutical manufacturers for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Daclatasvir drug substance and products.
• Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor and control impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to ensure compliance with ICH guidelines.
• Stability Studies: Used to identify and quantify degradation products formed during forced degradation and long-term stability studies of Daclatasvir.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Daclatasvir Impurity E
CAS No.	1009113-58-9
Molecular Formula	C40H50N8O6
Molecular Weight	738.88 g/mol
Synonyms	Daclatasvir Related Compound E; BMS-790052 Impurity E; (1R,3S,6R,7S,8S,11S,12R,14S)-12-[[(2S)-2-[[(1,1-Dimethylethoxy)carbonyl]amino]-3,3-dimethyl-1-oxobutyl]amino]-2,15-dioxo-3,6,7,8,11,12,13,14,15,16-decahydro-2H-cyclopropa[5,6]indolizino[1,2-b]quinoline-7,14-diyl dimethyl dicarbamate; Daclatasvir EP Impurity E; Daclatasvir USP Impurity E
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity E is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and controlled per current ICH Q3A, Q3B, and Q6A guidelines. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, and assay by validated methods such as HPLC and NMR.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
Water Content (KF)	≤ 1.0%
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.