Description

Levetiracetam Impurity 2 is a designated impurity standard used in the pharmaceutical development and quality control of the antiepileptic drug Levetiracetam. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Levetiracetam Impurity 2 in active pharmaceutical ingredients (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) used in impurity profiling.
• Quality Control and Batch Release Testing: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research and Development: Used in synthetic route optimization and process chemistry to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Levetiracetam Impurity 2
CAS No.	1341459-52-6
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 B; Levetiracetam EP Impurity B; Levetiracetam USP Impurity B; Keppra Impurity B; UCB L059 Impurity
EINECS	Contact for details

Quality Control

Every batch of Levetiracetam Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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