Description

Levetiracetam Impurity 31 is a specified impurity and degradation product of the antiepileptic drug Levetiracetam, critical for pharmaceutical research and development. This compound is essential for analytical method development, stability studies, and ensuring the safety and efficacy of the final drug product by monitoring and controlling impurity profiles. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals involved in the production and validation of Levetiracetam API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levetiracetam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods to accurately detect and measure impurity levels.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Levetiracetam and to establish appropriate shelf-life and storage conditions.
• Quality Control & Batch Release Testing: Serves as a system suitability standard in routine QC testing to ensure batches comply with pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Mechanisms: Used in academic and industrial research to study the chemical behavior and formation pathways of this specific impurity.

Basic Information

Product Name	Levetiracetam Impurity 31
CAS No.	20496-01-9
Molecular Formula	C8H14N2O3
Molecular Weight	186.21 g/mol
Synonyms	1-(2-Oxopyrrolidin-1-yl)butan-2-one; (RS)-1-(2-Oxopyrrolidin-1-yl)butan-2-one; 2-Butanone, 1-(2-oxo-1-pyrrolidinyl)-; Levetiracetam Related Compound; Keppra Impurity; UCB L059 Impurity; Levetiracetam Degradation Product
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity 31 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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