Description

Daclatasvir Impurity D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Daclatasvir, a key medication for treating Hepatitis C. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Daclatasvir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., to FDA, EMA) to establish impurity thresholds and control strategies as per ICH Q3A and Q3B.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of process-related impurities.

Basic Information

Item	Detail
Product Name	Daclatasvir Impurity D
CAS No.	1009117-26-3
Molecular Formula	C40H50N8O6
Molecular Weight	738.88 g/mol
Synonyms	Daclatasvir Related Compound D; BMS-790052 Impurity D; (1R,3S,6R,7S,8S,9S)-9-{4-[4-(2-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2H-pyrazol-3-yl)-1H-imidazol-2-yl]phenyl}-3-(2-methyl-2-propanyl)-1,2,3,4,6,7,8,9-octahydropyrido[1,2-a]pyrazin-7-yl carbamate; Daclatasvir EP Impurity D; Daclatasvir USP Impurity D; Daklinza Impurity D
EINECS	Contact for details

Quality Control

Our Daclatasvir Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and controlled against comprehensive specifications, including identity, purity, and impurity profile. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests such as HPLC purity, NMR, and MS for structural confirmation, ensuring compliance with relevant ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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