Description

Vigabatrin Ep Impurity B CAS NO 1379504-35-4 is a high-purity reference standard specifically used for the analytical profiling and quality control of the pharmaceutical active ingredient, Vigabatrin. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of this specific impurity during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of Vigabatrin.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Method Development and Validation: Crucial for developing and validating HPLC, UPLC, or GC methods to monitor Vigabatrin impurity profiles.
• Quality Control and Batch Release: Used in the routine QC testing of Vigabatrin drug substance and drug product to ensure compliance with pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Employed to identify and track the formation of this impurity over time under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process.
• Research and Development: Supports impurity identification and route scouting during the synthetic process development of Vigabatrin.

Basic Information

Product Name	Vigabatrin Ep Impurity B
CAS No.	1379504-35-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vigabatrin Impurity B; Vigabatrin Related Compound B; (3S,4S)-4-Amino-3-hydroxyhexanoic acid; (3S,4S)-4-Amino-3-hydroxyhexanoic acid impurity; Vigabatrin EP Impurity B; Sabril Impurity B; γ-Vinyl-GABA Impurity B
EINECS	Contact for details

Quality Control

Our Vigabatrin Ep Impurity B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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