2,6-di-tert-butyl-4-((3,5-di-tert-butyl-2-hydroxyphenyl)disulfanyl)phenol NEW

Probucol Impurity ;2093160-06-4

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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• Product Information

• Product Code：P063006

• English Name：Probucol Impurity 6

• English Alias：2,6-di-tert-butyl-4-((3,5-di-tert-butyl-2-hydroxyphenyl)disulfanyl)phenol

• CAS No.：2093160-06-4

• Molecular Formula：C₂₈H₄₂O₂S₂

• Molecular Weight：474.76

• Advantages

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

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 6 in Probucol API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Probucol synthesis, reducing generation by >40% by adjusting sulfidation temperature (e.g., 50-60℃) 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

• Probucol, an antioxidant, is used for treating hypercholesterolemia by inhibiting lipid peroxidation. Impurity 6, a disulfide-related impurity of Probucol, may originate from coupling side reactions of thiophenols during synthesis. Its disulfanyl, tert-butyl, and phenolic hydroxyl groups may affect drug antioxidant activity and stability. With stricter requirements for lipid-regulating drug impurities, studying this impurity is crucial for ensuring drug quality.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 10 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by coupling of 3,5-di-tert-butyl-2-hydroxybenzenethiol under oxidant (e.g., hydrogen peroxide) conditions; optimizing oxidant dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 198.6 μM against HepG2 cells (Probucol IC₅₀=12.5 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.

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 17386083646
E-mail: anna@molcoo.com

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