Description

Levetiracetam Impurity 19 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiepileptic drug Levetiracetam. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and monitoring during the manufacturing process. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Used for impurity profiling, batch release testing, and stability studies of Levetiracetam Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Facilitates studies on the degradation pathways, metabolism, and pharmacokinetics of Levetiracetam.
• Pharmacopoeial Testing: Employed in testing to meet the stringent impurity limits specified in pharmacopoeial monographs (USP, EP, BP).
• Contract Research Organizations (CROs): Essential tool for analytical service providers conducting outsourced drug substance and product testing.

Basic Information

Product Name	Levetiracetam Impurity 19
CAS No.	1868118-63-1
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; Levetiracetam EP Impurity I; Levetiracetam USP Impurity; Keppra Impurity; UCB L059 Impurity
EINECS	Contact for details

Quality Control

Every batch of Levetiracetam Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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