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 and production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Daclatasvir Impurity 7 in Daclatasvir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure API batches comply with strict pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Daclatasvir Impurity 7
CAS No.	28179-18-2
Molecular Formula	C40H50N8O6
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir Related Compound 7; BMS-790052 Impurity 7; (1R,3aS,6aR)-N-[(1S)-1-[(2S)-2-[[(1S,4R)-4-[4-[4-[[(2S)-1-[(2S)-2-[(Methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1,3-thiazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]-2,3,3a,4,5,6a-hexahydro-1H-cyclopenta[c]pyrrole-1-carboxamide; Daclatasvir EP Impurity G; Daclatasvir USP Impurity G
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.