Description

Brivaracetam Impurity 30 is a designated impurity 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 product purity, safety, and regulatory compliance. It is primarily used as a reference standard in the development and validation of chromatographic methods for impurity identification and quantification.

Application

• Primary use as a certified reference standard for the analysis of Brivaracetam drug substance and finished pharmaceutical products.
• Critical component in method development and validation for HPLC and UPLC assays in quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Brivaracetam formulations.
• Essential for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of synthetic routes and purification processes for Brivaracetam.
• Employed in pharmacopoeial testing to verify compliance with established monographs and specifications.

Basic Information

Product Name	Brivaracetam Impurity 30
CAS No.	22530-99-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brivaracetam Related Compound 30; (2S)-2-[(4R)-2-Oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide Impurity; UNII-6F8X7A6K6F; 1-(1-Oxobutan-2-yl)-4-propylpyrrolidin-2-one; A potential impurity of Brivaracetam; Brivaracetam EP Impurity G; Brivaracetam Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 30 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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