Description

Felbamate Ethyl Impurity is a critical reference standard used in the analytical profiling and quality control of the antiepileptic drug Felbamate. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and control this specific process-related impurity, ensuring the final drug product's safety, efficacy, and compliance with stringent regulatory guidelines. Its primary application is within the pharmaceutical development and quality assurance sectors, particularly for companies involved in the synthesis, formulation, and batch release of Felbamate.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of the ethyl impurity in Felbamate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Batch Release: Critical for routine QC testing to ensure impurity levels are within the limits specified by pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Process Chemistry Research: Used by R&D chemists to optimize synthesis pathways and minimize the formation of this specific by-product.

Basic Information

Item	Details
Product Name	Felbamate Ethyl Impurity
CAS No.	53054-24-3
Molecular Formula	C11H14N2O4
Molecular Weight	238.24 g/mol
Synonyms	2-Phenyl-1,3-propanediol dicarbamate ethyl ester; Ethyl Felbamate Impurity; Felbamate Related Compound; 2-Phenyl-1,3-propanediol bis(ethylcarbamate); 1,3-Bis(ethoxycarbonylamino)-2-phenylpropane; Felbamate Process Impurity; Felbatol Impurity
EINECS	Contact for details

Quality Control

Our Felbamate Ethyl Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with the requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), identity (by IR, NMR), and related substance data is provided with every 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) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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