Description

Vigabatrin Ep Impurity F is a specified impurity and degradation product of the antiepileptic drug Vigabatrin, identified by CAS No. 794466-81-2. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Vigabatrin active pharmaceutical ingredients (APIs) and finished dosage forms. It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists in the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Vigabatrin Ep Impurity F in drug substances and products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods, primarily using HPLC and UPLC.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure Vigabatrin API and drug products meet ICH guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate understanding and control of product-related impurities.
• Pharmacopeial Testing: Applied for compliance testing against monographs in the European Pharmacopoeia (EP) and United States Pharmacopeia (USP) where this impurity is specified.

Basic Information

Product Name	Vigabatrin Ep Impurity F
CAS No.	794466-81-2
Molecular Formula	C6H11NO2
Molecular Weight	129.16 g/mol
Synonyms	4-Amino-5-hexenoic acid; (RS)-4-Aminohex-5-enoic acid; Vigabatrin Impurity F; Vigabatrin Related Compound F; (R,S)-Vigabatrin Impurity F; 5-Hexenoic acid, 4-amino-; EP Impurity F of Vigabatrin
EINECS	Contact for details

Quality Control

Every batch of Vigabatrin Ep Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications. Our quality commitment aligns with cGMP principles to support our global pharmaceutical clientele.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.