Description

Brivaracetam Impurity 7 is a specified, structurally characterized impurity associated with the active pharmaceutical ingredient Brivaracetam. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories involved in the development and production of Brivaracetam.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Brivaracetam and its related substances.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Brivaracetam drug substance and drug products.
• Stability Studies & Degradation Profiling: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability and identification standard in routine QC testing to ensure impurity levels are within specified limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Process Chemistry: Used in research to understand the formation pathways of this impurity during the synthesis of Brivaracetam, aiding in process optimization.

Basic Information

Product Name	Brivaracetam Impurity 7
CAS No.	748760-80-7
Molecular Formula	C11H20N2O2
Molecular Weight	212.29 g/mol
Synonyms	(2S)-2-[(4R)-2-Oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide; (2S)-2-[(4R)-2-Oxo-4-propyl-1-pyrrolidinyl]butyramide; Brivaracetam Related Compound 7; Brivaracetam EP Impurity G; Brivaracetam USP Impurity; UCB 34714 Impurity; (S)-2-((R)-2-Oxo-4-propylpyrrolidin-1-yl)butanamide
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 7 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality commitment includes comprehensive characterization using techniques such as HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment, supporting compliance with cGMP and relevant pharmacopoeial guidelines (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.