Description

Vigabatrin Impurity 1 CAS NO 2324151-81-5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Vigabatrin by enabling precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vigabatrin API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity characterization reports as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Vigabatrin formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, synthesis impurities, and metabolism of Vigabatrin.

Basic Information

Product Name	Vigabatrin Impurity 1
CAS No.	2324151-81-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vigabatrin Related Compound 1; Vigabatrin Impurity; Vigabatrin EP Impurity; Vigabatrin USP Impurity; Sabril Impurity; (S)-4-Amino-5-hexenoic Acid Impurity; 4-Aminohex-5-enoic Acid Impurity; Vigabatrin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Vigabatrin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and identification data, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis/label. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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