Brivaracetam Impurity 48
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E-mail: anna@molcoo.com
Product Code：B017048
English Name：Brivaracetam Impurity 48
English Alias：2-((R)-2-oxo-4-propylpyrrolidin-1-yl)butanoic acid
CAS No.：Not provided
Molecular Formula：C₁₁H₁₉NO₃
Molecular Weight：213.27
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Brivaracetam impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 48 in Brivaracetam API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Brivaracetam synthesis, reducing generation by >30% by adjusting pyrrolidinone condensation 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).
Brivaracetam, a novel antiepileptic drug, exerts antiepileptic effects by selectively binding to synaptic vesicle protein 2A (SV2A), used as adjunctive therapy for partial-onset seizures in adults and children. Impurity 48, a process-related impurity in its synthesis, may originate from alkylation side reactions of pyrrolidinone rings or incomplete condensation reactions. Its ketone group, pyrrolidine ring, and propyl side chain may affect drug lipophilicity, metabolic stability, and safety. Strict impurity control for antiepileptic drugs is critical to drug quality, making research on this impurity essential.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by nucleophilic substitution of (R)-4-propyl-2-pyrrolidinone with 2-bromobutyric acid under alkaline catalyst (e.g., potassium carbonate); optimizing catalyst dosage and reaction pH inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 186.7 μM against SH-SY5Y nerve cells (Brivaracetam 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 high temperature and humidity 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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