Description

Levetiracetam Impurity (L-2-Aminobutanamide HCl, S-2-Aminobutanamide HCl) is a critical reference standard used in the pharmaceutical development and quality control of the antiepileptic drug Levetiracetam. This compound is essential for the accurate identification, quantification, and control of process-related impurities and enantiomeric purity during API synthesis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Levetiracetam Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Research & Development: Used in HPLC, UPLC, and LC-MS methods for the identification and quantification of enantiomeric impurities to confirm the stereochemical purity of the final drug substance.
• Process Chemistry & Optimization: Employed to monitor and control the synthesis pathway of Levetiracetam, helping to minimize impurity formation and improve overall yield and purity.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies as per ICH Q3A and Q3B guidelines.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track impurity formation under various stress conditions.

Basic Information

Product Name	Levetiracetam Impurity (L-2-Aminobutanamide HCl, S-2-Aminobutanamide HCl)
CAS No.	1933471-30-7
Molecular Formula	C4H10N2O • HCl
Molecular Weight	138.60 (Free base) / 175.02 (HCl salt)
Synonyms	(S)-2-Aminobutanamide Hydrochloride; (R)-2-Aminobutanamide Hydrochloride; 2-Aminobutyramide Hydrochloride; Levetiracetam Related Compound; (S)-2-Aminobutyric acid amide hydrochloride; L-2-Aminobutanamide HCl; S-2-Aminobutanamide HCl; 2-Aminobutanamide enantiomer HCl
EINECS	Contact for details

Quality Control

Every batch of our Levetiracetam Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) that include data from advanced chromatographic techniques. Our quality system is designed to meet the exacting standards of pharmaceutical impurity analysis, supporting compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Specific Rotation	Contact for details
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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