Description

Levetiracetam Impurity F is a specified impurity used in the quality control and analytical development 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 standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

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 methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Levetiracetam meets the purity specifications outlined in pharmacopeias (USP, EP, BP).
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light) to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Serves as a key impurity in synthetic route optimization and process chemistry research for Levetiracetam manufacturing.

Basic Information

Product Name	Levetiracetam Impurity F
CAS No.	358629-53-5
Molecular Formula	C8H14N2O3
Molecular Weight	186.21 g/mol
Synonyms	(2S)-2-(2-Oxopyrrolidin-1-yl)butanamide; 1-[(2S)-2-Aminocarbonylbutyl]-2-pyrrolidinone; Levetiracetam Related Compound F; Levetiracetam EP Impurity F; Keppra Impurity F; UCB L059 Impurity F; SIB Impurity F
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.