Probucol Impurity 186503-04-8
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E-mail: anna@molcoo.com
Product Information
Product Number: P063032
English Name: Probucol Impurity 32
English Alias: 4,4'-pentasulfanediylbis(2,6-di-tert-butylphenol)
CAS Number: 186503-04-8
Molecular Formula: C28H42O2S5
Molecular Weight: 570.96
Advantages: As a reference standard for Probucol Impurity 32, it features a well-defined chemical structure with high purity (≥95%) and excellent batch-to-batch stability, maintaining integrity under various storage conditions (e.g., light-protected, low temperature). Its rigorous quality control ensures reliable benchmarking in impurity detection for probucol bulk drugs and formulations, supporting validation of analytical methods such as HPLC and GC-MS, and ensuring accuracy and reproducibility in drug quality control.
Applications:
Quality Research: Used to develop detection methods for Impurity 32 in probucol, such as optimizing HPLC mobile phase ratios or GC-MS ion source parameters to achieve precise quantification of trace impurities (typically ≤0.1%).
Process Optimization: By analyzing the formation node of Impurity 32 in the synthesis pathway (e.g., as a byproduct of sulfidation reactions), it assists R&D personnel in adjusting reaction temperature, time, or catalyst dosage to reduce impurity generation.
Stability Assessment: Monitors the content changes of Impurity 32 under accelerated degradation tests (e.g., high temperature, high humidity) to provide data for establishing drug storage conditions.
Compliance Testing: Meets the requirements of regulatory agencies such as FDA and EMA for drug impurity profile analysis, ensuring products adhere to international quality standards.
Background Description: Probucol is a lipid-lowering drug that inhibits cholesterol synthesis and promotes its degradation. In production, incomplete control of thio-reactions may lead to the formation of polysulfide impurities (such as Impurity 32). These sulfur-containing impurities can affect the oxidative stability of the drug and pose potential toxic risks. Therefore, strict control of Impurity 32 is a critical aspect of probucol's quality system, directly impacting drug safety and efficacy.
Research Status:
Detection Technology: The mainstream method is HPLC-UV using a C18 column (e.g., 4.6×250mm, 5μm), with acetonitrile-water (75:25, v/v) as the mobile phase and a detection wavelength of 280nm, achieving a limit of quantification (LOQ) of 0.05% (S/N≥10). Some laboratories employ UHPLC-MS technology to shorten analysis time to within 10 minutes and enable rapid structural confirmation of impurities.
Formation Mechanism: Studies indicate that Impurity 32 originates from condensation reactions involving sodium hydrosulfide or sodium polysulfide, with its yield closely related to the type of sulfur source and the pH of the reaction system. Replacing with sodium thiosulfate or controlling the reaction pH at 8-9 can reduce Impurity 32 content by over 50%.
Safety Evaluation: In vitro toxicology experiments show that Impurity 32 may cause mild oxidative stress in hepatocytes at concentrations exceeding 0.5%, suggesting a limit of ≤0.1% in drug standards. Currently, companies have controlled its content below 0.03% through optimized crystallization processes.
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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