Bempedoic Acid Impurity 38 CAS 89541-21-9

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.89541-21-9
Molecular FormulaC13H23BrO4
Molecular Weight323.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bempedoic Acid Impurity 38 CAS 89541-21-9 chemical structure

Description

The occurrence of Bempedoic Acid Impurity 38 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Bempedoic Acid Impurity 38 (CAS 89541-21-9, C13H23BrO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Bempedoic Acid Impurity 38 (C13H23BrO4) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC13H23BrO4
Molecular Weight323.22 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1982
Halogen ContentBr-containing

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