Vonoprazan Impurity 76(Quaternary Ammonium)

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Product Number: V007076A
English Name: Vonoprazan Impurity 76(Quaternary Ammonium)
English Alias: 1-isopropylpyridin-1-ium-3-sulfonate
CAS Number: None
Molecular Formula: C₈H₁₁NO₃S
Molecular Weight: 201.24
As Impurity 76 of Vonoprazan (in quaternary ammonium form), this compound has the following advantages:
Well-defined with distinct functional groups: Contains 1-isopropylpyridinium cation and 3-sulfonate anion. Unlike vonoprazan (potassium-competitive acid blocker with non-quaternized pyridine), its quaternary ammonium polarity, sulfonate hydrophilicity, and isopropyl hydrophobicity create significant differences, enabling precise differentiation via ion-exchange chromatography/HPLC as a specific marker;
High stability and water solubility: Rigid pyridinium structure and quaternary ammonium ionic bonding ensure stability across a wide pH range, with excellent water solubility facilitating dissolution in aqueous systems for accurate and reproducible analysis;
High detection sensitivity: Pyridinium conjugation shows strong UV absorption (240-270nm), combined with m/z 202 [M]⁺ (cationic moiety) enabling ppb-level analysis via LC-MS, compatible with potassium-competitive acid blocker quaternary ammonium impurity systems.
Pharmaceutical quality control: Used as an impurity reference standard to quantify Vonoprazan Impurity 76(Quaternary Ammonium) in APIs, ensuring residual quaternized byproducts meet quality standards;
Synthesis optimization: Optimizing pyridine ring reaction conditions (isopropylation reagent dosage) by monitoring impurity levels to reduce quaternization and enhance target specificity;
Degradation pathway analysis: Identifying pyridine quaternization as a potential degradation route to guide storage and formulation improvements.
Vonoprazan is a potassium-competitive acid blocker with a pyridine ring. During synthesis or storage, excessive isopropylation (e.g., reagent excess) may cause quaternization of its pyridine ring, forming 1-isopropylpyridin-1-ium-3-sulfonate derivatives like Vonoprazan Impurity 76(Quaternary Ammonium). Due to strong polarity altering lipophilicity, its residues impact vonoprazan absorption and efficacy, requiring strict control.
Current research focuses on:
Analytical method validation: Developing ion-exchange chromatography with strong cation-exchange columns for separation, achieving 0.1 ppb detection limits;
Quaternization kinetics: Studying impurity formation under varying isopropylation reagent concentrations to clarify pyridine quaternization pathways;
Control strategies: Optimizing isopropylation parameters (low temperature) to keep impurity levels below 0.1% and enhance API purity;
Structural confirmation: Using ¹H/¹³C-NMR and ion chromatography to verify quaternary ammonium structure, distinguishing from vonoprazan for authoritative identification.
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