Description

Daclatasvir impurity 7/Daclatasvir RRSS Isomer/dimethyl (2R,2'S)-1,1'-((2R,2'R)-2,2'-(5,5'-(biphenyl-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate is a critical stereoisomeric impurity and reference standard essential for the analytical profiling and quality control of the antiviral drug Daclatasvir. This high-purity compound is vital for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific isomer during development and production. It is primarily used by pharmaceutical R&D teams, quality control (QC) analysts, and regulatory affairs specialists involved in the synthesis and commercialization of direct-acting antiviral (DAA) therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in Daclatasvir API and finished product analysis.
• Method Development and Validation: Critical for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor and control the levels of the RRSS isomer impurity, ensuring batch-to-batch consistency and purity specifications are met.
• Stability Studies: Employed to identify and track the formation of this degradation product or process-related impurity during forced degradation and long-term stability studies of Daclatasvir.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Used in synthetic chemistry research to study the stereochemistry and metabolic pathways of Daclatasvir and related compounds.

Basic Information

Item	Details
Product Name	Daclatasvir impurity 7/Daclatasvir RRSS Isomer/dimethyl (2R,2'S)-1,1'-((2R,2'R)-2,2'-(5,5'-(biphenyl-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate
CAS No.	1009117-94-5
Molecular Formula	C40H50N8O6
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir Impurity 7; Daclatasvir RRSS Isomer; BMS-790052 Impurity 7; (2R,2'S)-Daclatasvir dimethyl dicarbamate isomer; Dimethyl (2R,2'S)-1,1'-((2R,2'R)-2,2'-(5,5'-(biphenyl-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate; Daclatasvir Stereoisomer; Daclatasvir Related Compound R
EINECS	Contact for details

Quality Control

Every batch of our Daclatasvir Impurity 7 is manufactured and analyzed under strict quality systems. The product undergoes rigorous testing using advanced techniques like HPLC, LC-MS, and NMR to confirm identity, purity, and isomeric composition. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with ICH Q3A, Q3B, and current Good Manufacturing Practice (cGMP) standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a cool, dry place. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Isomeric Purity (HPLC)	≥ 99.0% (RRSS Isomer)
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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