Description

Levetiracetam M is a key pharmaceutical intermediate and reference standard in the synthesis of modern antiepileptic drugs. This compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of neurological therapeutics.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Levetiracetam and related anticonvulsant APIs.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of drug substances and products.
• Process Development: Serves as a key material in research and development for optimizing synthetic routes and scaling up production.
• Impurity Profiling: Employed as a marker to identify, quantify, and control related substances in accordance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Academic & Clinical Research: Supports studies investigating the metabolism, pharmacokinetics, and structure-activity relationships of pyrrolidone derivatives.

Basic Information

Product Name	Levetiracetam M
CAS No.	2245069-23-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-2-(2-Oxopyrrolidin-1-yl)butanamide Impurity M; Levetiracetam Related Compound M; 1-[(2S)-2-Aminobutanoyl]pyrrolidin-2-one; Levetiracetam EP Impurity M; Levetiracetam USP Impurity M; Keppra Impurity M
EINECS	Contact for details

Quality Control

Our Levetiracetam M is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent specifications. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.