Description

Daclatasvir Di-Descarbamate Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of antiviral medications. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) by serving as a known impurity for analytical method validation. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers focused on hepatitis C virus (HCV) therapeutics. The availability of a well-characterized impurity standard is essential for regulatory compliance and maintaining high standards in drug production.

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: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor process-related impurities.
• Quality Assurance & Control (QA/QC): Employed in routine testing within pharmaceutical QC laboratories to ensure API purity meets pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions during drug product shelf-life studies.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Daclatasvir Di-Descarbamate Impurity
CAS No.	1009119-18-9
Molecular Formula	C40H50N8O6
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir Di-Descarbamate; BMS-790052 Di-Descarbamate; (1R,3aS,6aR)-N-[(1S)-1-[(2S)-2-[[(1R,2R)-2-[[(7S)-6,7-Dihydro-5H-pyrrolo[3,4-d]pyrimidin-7-yl]oxy]-1-methyl-2-[(1-methylethyl)amino]carbonyl]cyclopropyl]carbonyl]-2-(4-fluorophenyl)ethyl]-1,2,3,3a,4,6a-hexahydrocyclopenta[c]pyrrole-5-carboxamide; Daclatasvir Impurity; Daclatasvir Related Compound
EINECS	Contact for details

Quality Control

Every batch of Daclatasvir Di-Descarbamate Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) are available upon request, providing full traceability and detailed analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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