Description

Mexiletine Impurity D is a specified impurity of the antiarrhythmic drug Mexiletine, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development, validation, and routine testing of Mexiletine and related pharmaceutical substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Mexiletine Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC, UPLC, or GC, to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure that Mexiletine batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Mexiletine to understand its degradation pathways.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry R&D to study the formation and mitigation of this specific impurity during the synthesis of Mexiletine.

Basic Information

Product Name	Mexiletine Impurity D
CAS No.	26583-71-1
Molecular Formula	C11H16ClNO
Molecular Weight	213.70 g/mol
Synonyms	1-(2,6-Dimethylphenoxy)-2-propanamine Hydrochloride; 2-Amino-1-(2,6-dimethylphenoxy)propane Hydrochloride; Mexiletine Related Compound D; Mexiletine EP Impurity D; Mexiletine Hydrochloride Impurity D; 1-(2,6-Xylenoxy)-2-aminopropane Hydrochloride; DL-1-(2,6-Dimethylphenoxy)-2-propylamine Hydrochloride
EINECS	Contact for details

Quality Control

Our Mexiletine Impurity D is manufactured and tested under strict quality systems. Each batch undergoes comprehensive analytical characterization to ensure identity, purity, and traceability, aligning with ICH Q3A/B guidelines. A detailed Certificate of Analysis (COA) is provided, which includes data from HPLC, NMR, and MS analyses. The product is suitable for use as a reference standard in pharmaceutical applications.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.