Description

Mexiletine n-Carbonyloxy β-D-Glucuronide Sodium Salt is a high-purity, chemically defined reference standard and synthetic intermediate. This compound is critical for analytical method development, validation, and pharmacokinetic studies in pharmaceutical research and quality control. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in the development and production of the antiarrhythmic agent Mexiletine and its metabolites.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of Mexiletine metabolites in biological matrices and pharmaceutical formulations.
• Metabolite Research: Essential for studying the Phase II glucuronidation metabolic pathway of Mexiletine, aiding in drug metabolism and pharmacokinetics (DMPK) research.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and LC-MS/MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling: Employed as a characterized impurity standard to ensure the purity and safety of Mexiletine active pharmaceutical ingredient (API) during manufacturing.
• Synthetic Intermediate: Acts as a key building block in the chemical synthesis of labeled (e.g., deuterated) analogs of Mexiletine metabolites for use as internal standards.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive characterization data for drug metabolites as required by ICH guidelines.

Basic Information

Item	Detail
Product Name	Mexiletine n-Carbonyloxy β-D-Glucuronide Sodium Salt
CAS No.	915202-34-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mexiletine N-Carboxy Glucuronide Sodium Salt; Mexiletine Acyl Glucuronide Sodium Salt; 1-(2,6-Dimethylphenoxy)-2-propanamine N-Carboxy-β-D-Glucopyranosiduronic Acid Sodium Salt; Mexiletine β-D-Glucuronide (Acyl); Sodium (2S,3S,4S,5R,6S)-6-((1-(2,6-dimethylphenoxy)propan-2-yl)carbamoyloxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Mexiletine n-Carbonyloxy β-D-Glucuronide Sodium Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical research and development. A comprehensive Certificate of Analysis (COA), detailing results for assay, purity, and identification tests, is provided with each shipment to support your regulatory and quality assurance 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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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