Description

Brivaracetam Impurity 3 is a designated impurity of the antiepileptic drug Brivaracetam, identified by the CAS registry number 2432911-32-3. This high-purity reference standard is critical for analytical research and development, enabling precise identification, quantification, and control of this specific impurity during pharmaceutical manufacturing. It is an essential material for quality control laboratories, regulatory compliance, and method validation in the pharmaceutical industry, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Brivaracetam drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of Brivaracetam Impurity 3 to meet ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions to establish product shelf-life.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Brivaracetam Impurity 3
CAS No.	2432911-32-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	UNII-8V8T4Q5W6M; (2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide impurity 3; Brivaracetam Related Compound 3; Brivaracetam EP Impurity C; Brivaracetam USP Related Compound C; A specific process-related impurity of Brivaracetam.
EINECS	Contact for details

Quality Control

Our Brivaracetam Impurity 3 is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against stringent in-house specifications aligned with ICH Q3A/B guidelines. Our quality system is designed to support regulatory requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if the compound is found to be sensitive.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.