Trimetazidine Impurities and Trimetazidine
Daicel Pharma is a reliable supplier of high-quality Trimetazidine impurities, encompassing N-Nitrosamine Trimetazidine HCl impurity and Trimetazidine-N-oxide. These impurities are vital in evaluating active pharmaceutical ingredients’ quality, stability, and safety. Additionally, Daicel Pharma specializes in the custom synthesis of Trimetazidine impurities, ensuring precise fulfillment of individual client requirements. With worldwide shipping capabilities, they are delivered to customers across the globe.
Trimetazidine [CAS: 5011-34-7] is a coronary vasodilator and prevents angina attacks. It is a metabolic modulator and improves myocardial metabolism during ischemia.
Trimetazidine: Use and Commercial Availability
Trimetazidine is for patients who experience angina (chest pain) due to reduced blood flow to the heart muscle. Its primary function is to improve blood flow to the heart, reducing the frequency and severity of angina episodes. Trimetazidine is also an adjunctive treatment for individuals with vertigo and tinnitus caused by vascular or degenerative factors.
Trimetazidine is available under brand names Vastarel, among others. It contains the active ingredient, Trimetazidine.
Trimetazidine Structure and Mechanism of Action
The chemical name of Trimetazidine is 1-[(2,3,4-Trimethoxyphenyl)methyl]piperazine. Its chemical formula is C14H22N2O3, and its molecular weight is approximately 266.34 g/mol.
Trimetazidine inhibits 3-ketoacyl-CoA thiolase and decreases long-chain fatty acid oxidation. It stimulates glucose metabolism and relieves chest pain caused by blocked blood vessels.
Trimetazidine Impurities and Synthesis
Trimetazidine impurities can arise during synthesis1 due to storage or using specific raw materials and intermediates in manufacturing. These impurities encompass related compounds, degradation products, and process impurities. Stringent quality control measures and analytical methods are crucial to ensure the purity and safety of Trimetazidine for patient use.
Daicel provides a comprehensive Certificate of Analysis (CoA) for Trimetazidine impurity standards such as N-Nitrosamine Trimetazidine.HCl and Trimetazidine-N-oxide. The CoA includes detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additionally, upon delivery, we give 13C-DEPT. Daicel possesses the technology and expertise to synthesize any unknown Trimetazidine impurity or degradation product. We also offer labeled compounds to quantify the efficacy of generic Trimetazidine. For bioanalytical research and BA/BE studies, Daicel supplies highly pure Trimetazidine nitroso D9 impurity and Trimetazidine-D9 dihydrochloride, deuterium-labeled standards of Trimetazidine.
- Souvie, Jean Claude, Process for the preparation of 1-(2,3,4-trimethoxybenzyl) piperazine by reductive amination, ADIR et Cie., France, EP453365B1, November 30, 1994
Frequently Asked Questions
A simple, sensitive, and precise RP-HPLC method is used to quantify Trimetazidine and its impurities. It utilizes various stationary and mobile phases.
Impurities in Trimetazidine can be a concern because they can affect the medication's quality, safety, and efficacy. Some impurities may be toxic or have undesirable effects on the body, potentially causing adverse reactions or reducing the effectiveness of the treatment.
In analytical techniques, water is used as a solvent to separate and detect Trimetazidine impurities.
Impurities in Trimetazidine are substances that can be present in the medication due to various factors such as the manufacturing process, storage conditions, or degradation. These impurities can include degradation products, residual solvents, or other related compounds that are not the desired active ingredient.
Trimetazidine Impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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