Description

Bempedoic Acid Impurity 1-D4 is a stable isotope-labeled deuterated compound, specifically designed as a certified reference material (CRM) for analytical applications. This high-purity impurity standard is critical for ensuring the accuracy and reliability of quantitative analysis in pharmaceutical research and development. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and regulatory compliance testing of Bempedoic Acid drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification and quantification of Bempedoic Acid Impurity 1 in drug substances and finished products.
• Analytical Method Development & Validation: Used as a spiking standard to develop, optimize, and validate sensitive and specific analytical methods, such as LC-MS/MS and HPLC.
• Metabolism and Pharmacokinetic (PK) Studies: Employed as an internal standard in mass spectrometry due to its deuterated structure, which provides nearly identical chromatographic behavior with a distinct mass shift, improving analytical precision.
• Quality Control & Stability Testing: Essential for monitoring impurity profiles during stability studies and routine quality control of Bempedoic Acid batches to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization and control of specified impurities, as required by ICH Q3A(R2) and Q3B(R2).
• Research on Degradation Pathways: Aids in studying the degradation chemistry of Bempedoic Acid under various stress conditions to understand impurity formation.

Basic Information

Product Name	Bempedoic Acid Impurity 1-D4
CAS No.	2408132-01-2
Molecular Formula	C18H30D4O5
Molecular Weight	Contact for details
Synonyms	8-Hydroxy-2,2,14,14-tetradeutero-8-oxotetradecanedioic Acid; (8R,9S,13S,14S)-3-[(1Z)-1,2-Bis(4-hydroxyphenyl)ethenyl]-13-methyl-6,7,8,9,11,12,13,14,15,16-decahydro-17H-cyclopenta[a]phenanthrene-3,17-diol-d4; Deuterated Bempedoic Acid Impurity; Bempedoic Acid Related Compound D4; ETC-1002 Impurity 1-D4; Deuterated ETC-1002 Impurity
EINECS	Contact for details

Quality Control

Every batch of Bempedoic Acid Impurity 1-D4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and isotopic enrichment verification using advanced techniques including NMR (1H, 13C), Mass Spectrometry, and HPLC. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines for reference 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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms to structure
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.