Description

Brivaracetam Impurity 7 Hcl is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiepileptic drug Brivaracetam. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working on method validation and regulatory compliance. The CAS number for this substance is 357338-46-6.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Brivaracetam Impurity 7 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to ensure Brivaracetam API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and level of this specific impurity in stability testing of the drug substance and product.
• Process Chemistry Research: Aids synthetic chemists in optimizing manufacturing processes to minimize the formation of this impurity.

Basic Information

Product Name	Brivaracetam Impurity 7 Hcl
CAS No.	357338-46-6
Molecular Formula	C11H21N2O2 • HCl
Molecular Weight	264.76 g/mol (free base: 213.30 g/mol)
Synonyms	(2S)-2-[(4R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide Hydrochloride; (2S)-2-[(4R)-2-Oxo-4-propyl-1-pyrrolidinyl]butanamide Hydrochloride; UCB 34714 Impurity; Brivaracetam Related Compound 7 HCl; Brivaracetam EP Impurity G HCl; Brivaracetam USP Impurity; 1-[(2S)-2-Aminocarbonylbutyl]-4-propyl-2-pyrrolidinone Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Brivaracetam Impurity 7 Hcl is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and impurity profile.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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