Description

Daclatasvir Impurity 5 (Srss-Isomer) is a specific stereoisomeric impurity associated with the antiviral drug Daclatasvir. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories and manufacturers involved in the production of Daclatasvir to ensure product purity, safety, and regulatory compliance. The CAS number for this material is 1009117-28-5.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for the identification and quantification of impurities in Daclatasvir active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing, validating, and verifying chromatographic methods (e.g., HPLC, UPLC) to monitor the Srss-isomer impurity profile during API synthesis.
• Quality Assurance & Control (QA/QC): Used in routine batch release testing to ensure Daclatasvir drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies for drug approval.
• Process Chemistry Research: Aids chemists in optimizing synthetic pathways to minimize the formation of this isomer, thereby improving the yield and purity of the final API.

Basic Information

Product Name	Daclatasvir Impurity 5 (Srss-Isomer)
CAS No.	1009117-28-5
Molecular Formula	C₄₀H₅₀N₈O₆
Molecular Weight	738.89 g/mol
Synonyms	Daclatasvir Related Compound 5; Daclatasvir Srss-Isomer; BMS-790052 Impurity 5; (2R,3R,4R,5R)-2-(2-((S)-((2S,3S)-1-((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-3-methyl-2-oxopyrrolidin-3-yl)-3-phenylpropanamido)-5-(4-(4-((2-((2S)-1-((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-oxopyrrolidin-2-yl)-1H-imidazol-5-yl)phenyl)carbamoyl)-2,6-dimethylphenoxy)pentyl)-6-azaspiro[3.4]octane-6-carboxylic acid
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Each batch is characterized using advanced analytical techniques including HPLC, MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality system supports compliance with relevant guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to preserve stability.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.