Description

Brivaracetam Impurity 10 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 analysis. 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 Brivaracetam Impurity 10 in Brivaracetam API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Brivaracetam API, complying with ICH Q3A and Q3B guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Brivaracetam formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data and specifications.
• Research and Development: Facilitates impurity profiling during the synthetic route development and process optimization of Brivaracetam.

Basic Information

Product Name	Brivaracetam Impurity 10
CAS No.	60559-16-2
Molecular Formula	C11H20N2O2
Molecular Weight	212.29 g/mol
Synonyms	(2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide; (2S)-2-[(4R)-2-Oxo-4-propyl-1-pyrrolidinyl]butanamide; UCB 34714; Brivaracetam Related Compound; Brivaracetam EP Impurity; Brivaracetam USP Impurity; Brivaracetam Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by chromatographic techniques (HPLC). Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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