Description

Mexiletine Rc 2 (Base) is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for the research, development, and quality control of antiarrhythmic medications. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories requiring a reliable and well-characterized building block for active pharmaceutical ingredient (API) synthesis.

Application

• Pharmaceutical Intermediate: Serves as a key precursor in the synthesis of Mexiletine hydrochloride, a Class IB antiarrhythmic agent.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing via HPLC, GC, or other chromatographic techniques.
• Research & Development: Essential for preclinical and clinical research studies investigating cardiac electrophysiology and new therapeutic formulations.
• Impurity Profiling: Employed as a marker to identify and quantify related substances in final drug products to ensure compliance with ICH guidelines.
• GMP Manufacturing: Integrated into controlled production processes for the manufacture of finished dosage forms under Good Manufacturing Practice standards.

Basic Information

Product Name	Mexiletine Rc 2 (Base)
CAS No.	117322-92-6
Molecular Formula	C11H17NO
Molecular Weight	179.26 g/mol
Synonyms	1-(2,6-Dimethylphenoxy)-2-propanamine; 2,6-Dimethylphenoxyisopropylamine; 1-(2,6-Xyloxy)-2-propylamine; Mexiletine Impurity; Mexiletine Related Compound 2; Mexiletine Free Base; Mexiletine Base; 2-Propanamine, 1-(2,6-dimethylphenoxy)-
EINECS	Contact for details

Quality Control

Our Mexiletine Rc 2 (Base) is produced and tested under a rigorous quality management system. Each batch is analyzed to meet stringent specifications for identity, purity, and impurity profiles, aligning with pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) detailing results from tests such as HPLC assay, related substances, residual solvents, and identification is provided to ensure full traceability and compliance for your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any individual impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%

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