Description

Mexiletine Hydrochloride Ep Impurity C is a high-purity reference standard specifically used in the pharmaceutical development and quality control of the antiarrhythmic drug Mexiletine Hydrochloride. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity during manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and fine chemical sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development, validation, and verification in compliance with ICH guidelines.
• Impurity Profiling and Control: Used in HPLC, LC-MS, and GC-MS analyses to monitor and control the levels of Mexiletine Hydrochloride Ep Impurity C during active pharmaceutical ingredient (API) synthesis and purification processes.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to assess the degradation pathways and shelf-life stability of Mexiletine Hydrochloride drug substances and products.
• Quality Control Testing: Serves as a system suitability standard and for the routine quality control testing of commercial batches of Mexiletine Hydrochloride API.
• Research and Development: Facilitates process chemistry research aimed at minimizing or eliminating this impurity during synthesis scale-up.

Basic Information

Product Name	Mexiletine Hydrochloride Ep Impurity C
CAS No.	2059988-38-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mexiletine EP Impurity C; Mexiletine Hydrochloride Impurity C; Mexiletine Related Compound C; 1-(2,6-Dimethylphenoxy)-2-propanamine Hydrochloride Impurity; (RS)-1-(2,6-Dimethylphenoxy)-2-propanamine Hydrochloride Impurity C; Mexiletine HCl Impurity C
EINECS	Contact for details

Quality Control

Every batch of Mexiletine Hydrochloride Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Handle and store under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.