Description

Felbamate Related Compound B (25 Mg) (Phenethyl Carbamate) is a high-purity analytical reference standard essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker for the anticonvulsant drug Felbamate, ensuring product safety and regulatory compliance. It is primarily required by analytical chemists, quality assurance laboratories, and pharmaceutical manufacturers engaged in method development, validation, and stability testing.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of Phenethyl Carbamate in Felbamate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods to meet ICH Q2(R1) and USP guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of related substances in Felbamate under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Felbamate batches meet stringent pharmacopeial specifications for related substances.
• Regulatory Submissions and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity identification data required in Module 3 (Quality) of the Common Technical Document (CTD).
• Research and Development: Used in metabolic and pharmacokinetic studies to understand Felbamate's degradation pathways.

Basic Information

Product Name	Felbamate Related Compound B (25 Mg) (Phenethyl Carbamate)
CAS No.	6326-19-8
Molecular Formula	C10H13NO2
Molecular Weight	179.22 g/mol
Synonyms	Phenethyl Carbamate; 2-Phenylethyl Carbamate; Felbamate Impurity B; Felbamate Related Substance B; Carbamic Acid 2-Phenylethyl Ester; β-Phenylethyl Carbamate; NSC 401005; Benzeneethanamine, N-carboxy-
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and chromatographic data. Our quality system supports compliance with cGMP and relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle with standard laboratory precautions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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