Description

Levetiracetam Impurity B is a specified impurity and degradation product of the antiepileptic drug Levetiracetam. This compound is critical for pharmaceutical research, development, and quality control, serving as a key reference standard. It is primarily used by analytical laboratories and pharmaceutical manufacturers to ensure drug purity, safety, and regulatory compliance. The availability of a well-characterized impurity standard is essential for method validation and stability studies.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability-indicating assays for Levetiracetam API and finished dosage forms.
• Essential for quality control (QC) and quality assurance (QA) testing in pharmaceutical manufacturing.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity identification and qualification thresholds.
• Valuable for research and development studies on the degradation pathways and metabolism of Levetiracetam.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other international pharmacopoeias.

Basic Information

Product Name	Levetiracetam Impurity B
CAS No.	358629-47-7
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; UCB L059 Impurity B; SIB Impurity B of Levetiracetam
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity B is manufactured and handled under strict quality systems. Each batch is characterized and tested using validated analytical methods, including HPLC, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a high-purity reference standard for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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