Description

Brivaracetam Impurity 25 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Brivaracetam. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of antiepileptic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Brivaracetam API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (thermal, photolytic, hydrolytic) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., with FDA, EMA) to support drug approval processes.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the API development phase.

Basic Information

Product Name	Brivaracetam Impurity 25
CAS No.	10547-88-3
Molecular Formula	C11H20N2O3
Molecular Weight	228.29 g/mol
Synonyms	(2S)-2-[(4R)-2-Oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide; (2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide; A related substance of Brivaracetam; Brivaracetam Related Compound; Brivaracetam Impurity F (Potential); Brivaracetam EP Impurity F; Brivaracetam USP Impurity; UCB 34714 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 25 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results against established in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures the material is suitable for its intended use as a high-purity reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry environment to minimize moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
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.