Description

Levetiracetam Impurity 4 is a specified impurity and degradation product of the antiepileptic drug Levetiracetam, identified by the CAS number 1342229-32-6. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity. It is an essential material for analytical laboratories, regulatory compliance, and manufacturers committed to producing high-quality active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in accordance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Used in-house by API manufacturers to establish impurity profiles, set specifications, and ensure batch-to-batch consistency of Levetiracetam.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Analytical Laboratory Calibration: Serves as a system suitability standard for HPLC, UPLC, and LC-MS/MS instruments to ensure accurate impurity detection.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's formation pathways and potential impact.

Basic Information

Product Name	Levetiracetam Impurity 4
CAS No.	1342229-32-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levetiracetam Related Compound 4; (2S)-2-(2-Oxopyrrolidin-1-yl)butanamide Impurity 4; Levetiracetam EP Impurity D; Levetiracetam USP Related Compound 4; Keppra Impurity 4; UCB L059 Impurity 4; 1-[(2S)-2-Aminobutanoyl]pyrrolidin-2-one (specific isomer); Levetiracetam Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Levetiracetam Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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