Description

Daclatasvir Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Daclatasvir. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of antiviral medications.

Application

• Primary use as a reference standard for the identification and quantification of Daclatasvir Impurity 7 in Daclatasvir API and finished dosage forms.
• Essential for method development and validation of HPLC and UPLC analytical procedures in pharmaceutical R&D and QC laboratories.
• Critical component in stability studies and impurity profiling to monitor degradation pathways and ensure product shelf-life.
• Used for regulatory compliance and filing, supporting documentation for agencies like the FDA, EMA, and PMDA.
• Serves as a system suitability and calibration standard in routine quality control testing.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other international pharmacopoeias.

Basic Information

Product Name	Daclatasvir Impurity 7
CAS No.	1447744-93-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Daclatasvir Related Compound 7; Daklinza Impurity 7; BMS-790052 Impurity 7; (1R,3S,5R)-2-[(2S)-2-{[5-(4-{4-[2-((2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-pyrrolidinyl)-1H-imidazol-5-yl]phenyl}phenyl)-1H-imidazol-2-yl]carbonyl}-1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-2-azabicyclo[3.1.0]hex-3-yl]carbamic acid methyl ester
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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