Pregabalin Impurity NEW

Pregabalin Impurity；2361911-35-3

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: P006064

• English Name: Pregabalin Impurity 64

• English Alias: (4S,4'S)-1,1'-methylenebis(4-isobutylpyrrolidin-2-one)

• CAS Number: 2361911-35-3

• Molecular Formula: C₁₇H₃₀N₂O₂

• Molecular Weight: 294.43

• Advantages

• As an impurity reference standard for pregabalin, this compound has the following advantages:
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• Well-defined structure and high stability: The unique structure of dipyrrolidinone linked by a methylene group enables analysis of by-product formation mechanisms during pregabalin synthesis, such as condensation reactions, to optimize processes for impurity control;

• Nitrogen heterocycle standard substance: Characteristic structure with isobutyl, pyrrolidinone, and methylene bridge groups provides an accurate standard for HPLC, LC-MS, and other detection methods to improve separation and quantification accuracy of nitrogen heterocycle impurities;

• Facilitating process traceability: Analyzing the formation pathway of this impurity can trace raw material residues or reaction condition deviations in pregabalin synthesis, providing a basis for process optimization.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 64 in pregabalin and its formulations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of detection methods (e.g., HPLC, LC-MS), ensuring impurity content meets pharmacopoeia requirements during production;

• Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on pregabalin formulation stability.

• Background Description

• Pregabalin is a γ-aminobutyric acid (GABA) analog used for treating epilepsy, neuropathic pain, etc. During its synthesis, improper control of condensation reaction conditions or excessive raw materials easily generate dipyrrolidinone impurities with methylene bridge structures. Such impurities may affect drug safety and effectiveness, making research on pregabalin impurities a key part of drug quality control.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology, optimizing separation conditions by leveraging the characteristic ionization of nitrogen heterocycles to achieve trace detection;

• Synthesis process improvement: Reducing the generation of methylene-bridged by-products by optimizing the catalyst (such as potassium carbonate) and reaction temperature of condensation reactions;

• Toxicological evaluation: Evaluating the potential impact of this impurity on central nervous system cells through in vitro cytotoxicity experiments;

• Crystal form research: Analyzing the impact of impurity crystal form on the stability of pregabalin capsules to improve the quality control system

This product is intended for laboratory use only!

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