Bempedoic Acid Impurity NEW

Bempedoic Acid Impurity;7569-34-8

Product Information

• Product Code：B079028

• English Name：Bempedoic Acid Impurity 28

• English Alias：1-(ethylsulfonyl)-4-methylbenzene

• CAS No.：7569-34-8

• Molecular Formula：C₉H₁₂O₂S

• Molecular Weight：184.26

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Bempedoic Acid impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents (such as methanol, acetonitrile) within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 28 in Bempedoic Acid API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 28 formation during Bempedoic Acid synthesis, reducing generation by >40% by adjusting sulfonylation temperature (e.g., 0-5℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 4 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by oxidation of p-tolyl sulfide with oxidants (such as hydrogen peroxide); optimizing oxidant dosage and reaction temperature inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 205.6 μM against HepG2 cells (Bempedoic Acid IC₅₀=15.8 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

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