Brivaracetam Impurities
General Information
Brivaracetam Impurities and Brivaracetam
Daicel Pharma synthesizes Brivaracetam impurities of exceptional quality, such as Brivaracetam (alfa R, 4R)-Isomer (DS-2), Brivaracetam (Alfa R, 4S)-Isomer (Enantiomer), Brivaracetam (alfa S, 4S)-Isomer (DS-1), Brivaracetam EP Impurity-D,Brivaracetam methyl ester (2S,4R) Isomer, and so on. These impurities are crucial to assess the purity, reliability, and safety of Brivaracetam, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Brivaracetam impurities to meet clients’ demands for delivery worldwide.
Brivaracetam [CAS: 357336-20-0] is an anticonvulsant medication in combination with other drugs to treat partial-onset seizures. This orally available drug is a derivative of levetiracetam.
Brivaracetam: Use and Commercial Availability
Brivaracetam is an anticonvulsant similar in structure to levetiracetam. It treats localization-related epilepsies and a broader spectrum of epileptic disorders. The trade name for Brivaracetam is Briviact.
Brivaracetam Structure and Mechanism of Action 
The chemical name of Brivaracetam is (αS,4R)-α-Ethyl-2-oxo-4-propyl-1-pyrrolidineacetamide. Its chemical formula is C11H20N2O2, and its molecular weight is approximately 212.29 g/mol.
Brivaracetam has an affinity for synaptic vesicle protein 2A (SV2A) in the brain leading to an anticonvulsant effect. But, its mechanism of action is not known.
Brivaracetam Impurities and Synthesis
Impurities in Brivaracetam are organic impurities, inorganic impurities, and residual solvents. Organic impurities may include related substances formed during the synthetic process1, degradation products due to heat, light, or moisture, and impurities from starting materials. Inorganic impurities are metals or other inorganic substances that may arise during manufacturing. Residual solvents may also be present in the manufacturing process. They should be monitored and controlled within acceptable limits and regulatory guidelines during drug development.
Daicel Pharma offers a Certificate of Analysis (CoA) for Brivaracetam impurity standards, such as as Brivaracetam (alfa R, 4R)-Isomer (DS-2), Brivaracetam (Alfa R, 4S)-Isomer (Enantiomer), Brivaracetam (alfa S, 4S)-Isomer (DS-1), Brivaracetam EP Impurity-D,Brivaracetam methyl ester (2S,4R) Isomer, and so on, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Furthermore, on request, we can provide additional data like 13C-DEPT and CHN. Daicel Pharma can prepare unknown Brivaracetam impurities or degradation products. A complete characterization report accompanies every delivery.
References
FAQ's
References
- Differding, Edmond; Kenda, Benoit; Lallemand, Benedicte; Matagne, Alain; Michel, Philippe; Pasau, Patrick; Talaga, Patrice, 2-Oxo-1-Pyrrolidine Derivatives, Processes For Preparing Them And Their Uses, UCB, S.A., Belgium, WO0162726A2, August 30, 2001
- Vishweshwar, Vavilala; Babu, J. Moses; Muralikrishna, R., Development and validation of stability-indicating UPLC method for the determination of brivaracetam, its related impurities and degradation products, International Journal of Pharmaceutical Sciences and Research, Volume: 9, Issue: 6, Pages: 2315-2327, 2018
Frequently Asked Questions
How are the impurity limits set for Brivaracetam?
Impurity limits for Brivaracetam are determined based on safety and efficacy. The regulatory authorities, such as the USP and ICH, govern the impurity limits.
How are potential impurities identified during the manufacturing process of Brivaracetam?
During manufacturing, analytical tests detect and quantify potential impurities in the Brivaracetam drug substance. These tests include HPLC, LC-GC, NMR, and other methods to ensure the purity of the drug substance.
Which solvent helps in the analysis of Brivaracetam impurities?
Acetonitrile or Methanol are solvents used for analyzing many impurities in Brivaracetam.
What are the temperature conditions required to store Brivaracetam impurities?
Brivaracetam impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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