Brivaracetam Impurity 48 NEW

Brivaracetam Impurity 48

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

Product Information

• 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

Advantages

• 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.

Applications

• 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).

Background Description

Research Status

• 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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!