Description

3-Hydroxymexiletine is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug mexiletine. Its precise chemical structure makes it an essential reference standard for analytical research and a critical building block in the synthesis of specialized pharmaceutical compounds. This high-purity compound is primarily utilized by research institutions and pharmaceutical manufacturers engaged in drug metabolism studies, impurity profiling, and advanced chemical synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of mexiletine metabolites in bioanalytical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used in in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of mexiletine.
• Impurity Synthesis and Characterization: A critical material for synthesizing and qualifying specified impurities and degradation products in mexiletine active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Employed as a benchmark compound for developing and validating HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Chemical Synthesis Intermediate: Acts as a versatile synthon for the research-scale preparation of novel chemical entities and structural analogs for biological screening.

Basic Information

Product Name	3-Hydroxymexiletine
CAS No.	129417-37-4
Molecular Formula	C11H17NO2
Molecular Weight	195.26 g/mol
Synonyms	1-(2,6-Dimethylphenoxy)-3-hydroxy-2-propanamine; 3-Hydroxy-1-(2,6-xylyloxy)-2-propanamine; 3-Hydroxymexiletine; Mexiletine Hydroxy Metabolite; 1-(2,6-Dimethylphenoxy)-3-hydroxypropan-2-amine
EINECS	Contact for details

Quality Control

Our 3-Hydroxymexiletine is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity suitable for research and development. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by advanced chromatographic techniques. We support compliance with cGMP and ISO guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. The compound may be hygroscopic; keep the container tightly sealed to minimize exposure to moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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