Description

Daclatasvir Impurity F is a designated impurity reference 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 benchmark in chromatographic analysis. 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 impurities in Daclatasvir API batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Daclatasvir.
• Research & Development: Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Item	Details
Product Name	Daclatasvir Impurity F
CAS No.	1007884-60-7
Molecular Formula	C40H50N8O6
Molecular Weight	738.88 g/mol
Synonyms	Daclatasvir Related Compound F; BMS-790052 Impurity F; (1R,3aS,6aR)-N-[(1S)-1-[(2S)-2-[[(1S,4R)-4-[4-[4-[2-[(2S)-1-[(2S)-2-[(Methoxycarbonyl)amino]-3-methylbutanoyl]-2-pyrrolidinyl]-1H-imidazol-4-yl]phenyl]phenyl]-1,3-thiazol-2-yl]-1-pyrrolidinyl]carbonyl]-2-methylpropyl]decahydrocyclopropa[e]indole-1-carboxamide; Daclatasvir EP Impurity F; Daclatasvir USP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Daclatasvir Impurity F is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with pharmaceutical reference standard requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and purity.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.