Trandolapril Impurities and Trandolapril
Daicel Pharma is a reliable supplier of high-quality Trandolapril impurity standards, encompassing Trandolaprilat. These impurities are vital in evaluating active pharmaceutical ingredients’ quality, stability, and safety. Additionally, Daicel Pharma specializes in custom synthesis of Trandolapril impurities, ensuring precise fulfillment of individual client requirements. With worldwide shipping capabilities, these impurities can be conveniently delivered to customers across the globe, providing unparalleled convenience.
Trandolapril [CAS: 87679-37-6], classified as an angiotensin-converting enzyme inhibitor, is an antihypertensive medication formulated as an ester prodrug that manages hypertension.
Trandolapril: Use and Commercial Availability
Trandolapril is an antihypertensive medication that treats hypertension, including α/β blockers, ACE inhibitors, thiazide-like diuretics, and AT1 antagonists. Its active metabolite, trandolaprilat, is responsible for its therapeutic effects.
Trandolapril is available under the brand name Mavik. It contains the active ingredient, Trandolapril.
Trandolapril Structure and Mechanism of Action
The chemical name of Trandolapril is (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydro-1H-indole-2-carboxylic acid. Its chemical formula is C24H34N2O5, and its molecular weight is approximately 430.5 g/mol.
Trandolapril inhibits tissue ACE activity, reduces angiotensin II formation, and decreases vasoconstriction and aldosterone secretion.
Trandolapril Impurities and Synthesis
Trandolapril 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 Trandolapril for patient use.
Daicel provides a comprehensive Certificate of Analysis (CoA) for Trandolapril impurity standards such as Trandolaprilat. The CoA includes detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additionally, upon delivery, a complete 13C-DEPT is also provided. Daicel possesses the technology and expertise to synthesize any unknown Trandolapril impurity or degradation product. We also offer labeled compounds to quantify the efficacy of generic Trandolapril. For bioanalytical research and BA/BE studies, Daicel supplies highly pure Trandolapril-D5 and Trandolaprilat-D5, deuterium-labeled standards of Trandolapril.
- Urbach, Hansjoerg; Henning, Rainer; Teetz, Volker; Geiger, Rolf; Becker, Reinhard, Derivatives Of Bicyclic Amino Acids, Process For Their Preparation, Agents Containing Them And Their Use, As Well As Bicyclic Amino Acids As Intermediates, And Process For Preparing Them, Hoechst A.-G., Federal Republic of Germany, EP84164B1, January 28, 1987
- Leena A. Al-Hawash, Ashok K. Shakya, and Maher L. Saleem, Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms, Int J Anal Chem. 2015; 2015: 820517, 2015 Jan 31
Frequently Asked Questions
Trandolapril impurities are typically detected and quantified using analytical techniques such as high-performance liquid chromatography (HPLC).
The impurities present in Trandolapril can influence its pharmacokinetics, resulting in alterations in bioavailability, metabolism, and elimination processes.
Methanol and DCM are used as a solvent in analytical techniques to separate and detect Trandolapril impurities.
Manufacturers can employ strategies to maintain control over impurity levels in Trandolapril. They include utilizing premium-grade starting materials, carefully optimizing reaction conditions, implementing efficient purification techniques, and continuously monitoring impurity levels at every stage of the manufacturing process.
Trandolapril 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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