Description

4-Hydroxy Mexiletine is a key pharmaceutical intermediate and metabolite of the antiarrhythmic agent Mexiletine. This compound matters for its critical role in drug metabolism studies and the development of analytical reference standards. Pharmaceutical R&D laboratories and fine chemical manufacturers need it for impurity profiling, pharmacokinetic research, and the synthesis of advanced drug candidates.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of Mexiletine metabolites in bioanalytical studies.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathways and clearance mechanisms of Mexiletine.
• Impurity Synthesis and Profiling: Serves as a critical process-related impurity or degradation product in the quality control of Mexiletine Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development: Employed to validate HPLC, LC-MS, and other chromatographic methods for specificity, accuracy, and linearity in pharmaceutical analysis.
• Preclinical Research: Utilized in pharmacological and toxicological investigations to assess the safety and efficacy profile of Mexiletine and its derivatives.
• Chemical Synthesis: Acts as a versatile building block for the preparation of novel chemical entities and analogs in medicinal chemistry programs.

Basic Information

Product Name	4-Hydroxy Mexiletine
CAS No.	123363-66-6
Molecular Formula	C11H17NO2
Molecular Weight	195.26 g/mol
Synonyms	1-(2,6-Dimethylphenoxy)-2-propanol, 4-OH-Mexiletine; 4-Hydroxymexiletine; Mexiletine Hydroxy Metabolite; Mexiletine Impurity; 2-Propanol, 1-(2,6-dimethylphenoxy)-; 1-(2,6-Xylyloxy)-2-propanol
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Mexiletine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep the container tightly sealed to protect from 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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