Description

Levetiracetam Impurity 25 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) levetiracetam. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levetiracetam API and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance: Serves as a benchmark in QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (USP, EP, ICH).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions to determine drug shelf life.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Levetiracetam.

Basic Information

Product Name	Levetiracetam Impurity 25 Hcl
CAS No.	429673-89-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levetiracetam Related Compound 25 Hydrochloride; (2S)-2-(2-Oxopyrrolidin-1-yl)butanamide Impurity 25 HCl; 1-(2S)-2-Aminobutyryl)pyrrolidin-2-one Hydrochloride Impurity; UCB L059 Impurity 25 HCl; Keppra Impurity 25 Hydrochloride; SIB Impurity 25 HCl; Levetiracetam EP Impurity H HCl
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity 25 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and all test results is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	< 20 ppm

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