Description

Levetiracetam Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Levetiracetam. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levetiracetam API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure API and drug products meet stringent pharmacopeial specifications (USP, EP, ICH).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) over the product's shelf life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Levetiracetam.

Basic Information

Product Name	Levetiracetam Impurity 3
CAS No.	1543353-92-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levetiracetam Related Compound 3; (2S)-2-(2-Oxopyrrolidin-1-yl)butanamide Impurity 3; Keppra Impurity 3; 1-(2S)-2-Aminobutanoyl]pyrrolidin-2-one Impurity; Levetiracetam EP Impurity C; Levetiracetam Process Impurity; UCB L059 Impurity 3
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, MS, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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