Description

Levetiracetam Impurity 1 is a designated impurity of the antiepileptic drug Levetiracetam, crucial for pharmaceutical research, development, and quality control. This compound serves as a critical reference standard for the identification, quantification, and monitoring of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Levetiracetam.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Levetiracetam API to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed during drug substance and product stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Research on Degradation Pathways: Aids in studying the chemical behavior and degradation mechanisms of Levetiracetam under various conditions.

Basic Information

Product Name	Levetiracetam Impurity 1
CAS No.	1342566-28-2
Molecular Formula	C8H14N2O2
Molecular Weight	170.21 g/mol
Synonyms	(2S)-2-(2-Oxopyrrolidin-1-yl)butanamide; 1-[(2S)-2-Aminocarbonylbutyl]-2-pyrrolidinone; Levetiracetam Related Compound A; Levetiracetam EP Impurity A; Levetiracetam USP Related Compound A; UCB L059 Impurity; Keppra Impurity A
EINECS	Contact for details

Quality Control

Every batch of Levetiracetam Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
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.