Description

Bempedoic Acid Impurity 10 (CAS No. 1529323-27-0) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the manufacturing and quality assurance of Bempedoic Acid, a key active pharmaceutical ingredient. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of Bempedoic Acid and its related substances.
• Method Development & Validation: Used in developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in QC labs to monitor impurity levels and ensure API purity meets pharmacopeial standards (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of drug substances and products.
• Process Chemistry R&D: Aids chemists in optimizing synthesis routes by identifying and quantifying process-related impurities for purification strategy development.

Basic Information

Item	Details
Product Name	Bempedoic Acid Impurity 10
CAS No.	1529323-27-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bempedoic Acid Related Compound 10; ESP-55016 Impurity 10; (2R)-2-({4-[1-(4-Fluorophenyl)-2,5-dimethyl-1H-pyrrol-3-yl]-2-methylbutanoyl}oxy)malonic acid; ETC-1002 Impurity 10; 8-Hydroxy Bempedoic Acid Impurity; Bempedoic Acid Process Impurity; Bempedoic Acid Degradant
EINECS	Contact for details

Quality Control

Every batch of Bempedoic Acid Impurity 10 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 (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). Certificates of Analysis (COA) detailing batch-specific results are available upon request to support your regulatory and quality documentation needs.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.