Description

Darapladib-Impurity CAS NO 1389264-17-8 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Darapladib by serving as a key marker for impurity profiling and control. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical and biotechnology sectors, enabling compliance with stringent regulatory requirements for drug substance characterization.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities in Darapladib drug substance and drug products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection and separation.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the API.
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to understand the degradation pathways of Darapladib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Process Chemistry Research: Used to trace the formation of this impurity during API synthesis, aiding in process optimization and refinement.

Basic Information

Product Name	Darapladib-Impurity
CAS No.	1389264-17-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darapladib Related Compound; Darapladib Impurity Standard; SB-480848 Impurity; Lp-PLA2 Inhibitor Impurity; 1389264-17-8; (E)-N-[[4-(4-Butylphenyl)-6-methyl-2-pyrimidinyl]thio]-3-[4-[[(1,1-dimethylethyl)amino]carbonyl]-2-methoxyphenyl]-2-propenamide Impurity; Darapladib EP Impurity; Darapladib USP Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is fully characterized using advanced spectroscopic and chromatographic techniques. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity confirmation, and impurity profile. Our quality system is designed to support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. 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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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