Description

Retigabine-D4 Dihydrochloride is a deuterated, isotopically labeled form of the active pharmaceutical ingredient Retigabine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, where precise measurement is paramount. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and bioanalytical method validation.

Application

• Bioanalytical Method Development and Validation: Serves as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Retigabine and its metabolites in biological matrices.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Impurity Profiling and Characterization: Used as a reference compound in impurity identification and structural elucidation studies.
• Quality Control in Pharmaceutical Manufacturing: Supports in-process testing and final product release assays to ensure batch consistency and compliance with regulatory specifications.
• Forensic and Anti-Doping Analysis: Provides a definitive reference for the identification and confirmation of the parent compound in specialized testing protocols.

Basic Information

Product Name	Retigabine-D4 Dihydrochloride
CAS No.	1285886-70-5
Molecular Formula	C16H14D4F3N3O2·2HCl
Molecular Weight	416.23 g/mol
Synonyms	Ezogabine-D4 Dihydrochloride; N-(2-Amino-4-((4-fluorophenyl)methylamino)phenyl)-D4-carbamic acid ethyl ester dihydrochloride; D4-Retigabine Dihydrochloride; Ethyl (2-amino-4-((4-fluorobenzyl)amino)phenyl)carbamate-2,3,5,6-D4 Dihydrochloride; ICA-105665-D4 Dihydrochloride; N-[2-Amino-4-[(4-fluorophenyl)methylamino]phenyl]-D4-carbamic Acid Ethyl Ester Dihydrochloride
EINECS	Contact for details

Quality Control

Our Retigabine-D4 Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for chemical and isotopic purity, NMR for structural confirmation, and mass spectrometry for identity verification. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, water content, residual solvents, and other critical parameters to support your regulatory filings.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Enrichment)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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