Description

Brivaracetam Impurity 5 is a specified impurity of the antiepileptic drug Brivaracetam, identified by the CAS number 1942054-60-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and ensuring batch-to-batch consistency and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Brivaracetam API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine quality control testing to monitor impurity levels and ensure product safety and efficacy.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve manufacturing processes.

Basic Information

Product Name	Brivaracetam Impurity 5
CAS No.	1942054-60-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brivaracetam Related Compound 5; Brivaracetam EP Impurity 5; Brivaracetam USP Impurity 5; (2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide (process-related isomer); UCB 34714 Impurity; UCB-34714 Related Substance 5
EINECS	Contact for details

Quality Control

Our Brivaracetam Impurity 5 is manufactured under strict quality systems suitable for pharmaceutical analysis. Each batch is characterized and tested to ensure high purity and identity, aligning with the requirements of major pharmacopeias. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and related substances by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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

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