Description

Brivaracetam Impurity 28 is a designated reference standard used in the analytical profiling and quality control of the antiepileptic drug Brivaracetam. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for Brivaracetam-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Brivaracetam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Brivaracetam meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical stability and metabolic pathways of Brivaracetam.

Basic Information

Product Name	Brivaracetam Impurity 28
CAS No.	16496-51-8
Molecular Formula	C11H20N2O3
Molecular Weight	228.29 g/mol
Synonyms	(2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide; (2S)-2-[(4R)-2-Oxo-4-propyl-1-pyrrolidinyl]butanamide; Brivaracetam Related Compound; Brivaracetam EP Impurity; Brivaracetam USP Impurity; Brivaracetam Process Impurity; UCB 34714 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity (by HPLC), identification (IR, NMR), and related substances is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.