Description

Trimetazidine n-Oxide Dihydrochloride is a high-purity pharmaceutical intermediate and reference standard, specifically the dihydrochloride salt of the N-oxide derivative of trimetazidine. This compound is of significant value in research and development for its role in metabolic modulation studies and as a critical precursor in advanced pharmaceutical synthesis. It is primarily needed by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of active pharmaceutical ingredients (APIs) focusing on cardiology and metabolic disorders.

Application

• Pharmaceutical Reference Standard: Used for analytical method development, validation, and quality control (QC/QA) in pharmaceutical laboratories.
• Metabolic Research: Serves as a key intermediate in the study of trimetazidine's mechanism of action and the development of novel cardioprotective agents.
• Active Pharmaceutical Ingredient (API) Synthesis: A crucial precursor in the multi-step synthesis of trimetazidine and its related analogs.
• Impurity Profiling: Employed as a certified impurity standard to monitor and control the quality of trimetazidine API batches according to ICH guidelines.
• Preclinical & Clinical Research: Utilized in pharmacological and toxicological studies to investigate the properties of trimetazidine metabolites.
• Regulatory Documentation: Supports drug master file (DMF) submissions and regulatory compliance dossiers for market authorization.

Basic Information

Product Name	Trimetazidine n-Oxide Dihydrochloride
CAS No.	2731228-51-4
Molecular Formula	C14H22N2O3 · 2HCl
Molecular Weight	339.26 g/mol (free base: 266.34)
Synonyms	1-(2,3,4-Trimethoxybenzyl)piperazine N-Oxide Dihydrochloride; Trimetazidine N-Oxide 2HCl; Trimetazidine Impurity N-Oxide Dihydrochloride; Vastarel Metabolite N-Oxide Dihydrochloride; TMZ N-Oxide Dihydrochloride; Trimetazidine Related Compound N-Oxide Dihydrochloride
EINECS	Contact for details

Quality Control

Our Trimetazidine n-Oxide Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and IR for structural confirmation, and stringent control of residual solvents and related substances. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with relevant pharmacopeial and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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