Description

Levetiracetam Impurity 30 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Levetiracetam. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Levetiracetam Impurity 30 in API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical R&D and quality control laboratories.
• Critical component in stability studies and impurity profiling to monitor degradation pathways of Levetiracetam.
• Used for regulatory compliance and submission, providing necessary data for ICH guidelines (Q3A, Q3B) on impurities.
• Serves as a key material for pharmacopoeial testing to meet USP, EP, or other compendial standards.
• Supports generic drug development by enabling impurity characterization and comparison with the originator product.

Basic Information

Product Name	Levetiracetam Impurity 30
CAS No.	79194-54-0
Molecular Formula	C8H14N2O3
Molecular Weight	186.21 g/mol
Synonyms	1-(2-Oxopyrrolidin-1-yl)butan-2-yl carbamate; (S)-1-(2-Oxopyrrolidin-1-yl)butan-2-yl carbamate; Levetiracetam Related Compound 30; Levetiracetam EP Impurity G; Keppra Impurity 30; UCB L059 Impurity; (2S)-1-[(2-Oxo-1-pyrrolidinyl)]-2-butanyl carbamate
EINECS	Contact for details

Quality Control

Our Levetiracetam Impurity 30 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for use as a reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile. Quality is assured through compliance with relevant ICH guidelines and is suitable for use in methods intended to meet USP, EP, and other pharmacopoeial requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 Q3C
Water Content (KF)	≤ 0.5%

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