Description

Retigabine Dihydrochloride Impurity CAS NO 1432063-93-8 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Retigabine Dihydrochloride. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) focused on neurology and anticonvulsant drug development.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Used as a system suitability standard and for setting specification limits in the release testing of Retigabine Dihydrochloride API batches.
• Regulatory Compliance & Filing: Essential for identifying and characterizing impurities as required by ICH Q3A(R2) and Q3B(R2) guidelines for regulatory submissions to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Process Chemistry Research: Used to identify and track the source of this specific impurity during API synthesis and purification process optimization.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs that specify limits for related substances.

Basic Information

Item	Detail
Product Name	Retigabine Dihydrochloride Impurity
CAS No.	1432063-93-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Retigabine Related Compound; Retigabine Dihydrochloride Related Substance; Ezogabine Impurity; N-(2-Amino-4-(4-fluorobenzylamino)-phenyl)carbamic acid ethyl ester dihydrochloride impurity; D23129 Impurity; Trobalt Impurity; Potiga Impurity
EINECS	Contact for details

Quality Control

Every batch of Retigabine Dihydrochloride Impurity (CAS 1432063-93-8) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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