Description

Trimetazidine Impurity F is a specified impurity of the anti-anginal pharmaceutical agent Trimetazidine, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Trimetazidine drug substances and products. It is primarily required by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Trimetazidine.
• Impurity Profiling & Identification: Essential for identifying and quantifying Trimetazidine Impurity F in active pharmaceutical ingredients (APIs) and finished drug products during stability and release testing.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS, for impurity detection.
• Quality Control & Assurance: Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.

Basic Information

Product Name	Trimetazidine Impurity F
CAS No.	754147-91-6
Molecular Formula	C14H19N3O4
Molecular Weight	293.32 g/mol
Synonyms	1-[(2,3,4-Trimethoxyphenyl)methyl]piperazine-2,3-dione; Trimetazidine Related Compound F; Trimetazidine EP Impurity F; Trimetazidine USP Impurity F; TMZ Impurity F; 2,3-Dioxo-1-[(2,3,4-trimethoxyphenyl)methyl]piperazine
EINECS	Contact for details

Quality Control

Every batch of Trimetazidine Impurity F is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment and sealed tightly after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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