Description

Trandolapril-D5 is a stable isotope-labeled analog of the active pharmaceutical ingredient Trandolapril, specifically deuterated at five positions. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative analytical methods in pharmaceutical research and development. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors for applications such as method development, validation, and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of Trandolapril and its metabolites in biological matrices.
• Pharmacokinetic and Bioavailability Studies: Enables accurate tracking and measurement of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Method Development and Validation: Used as a certified reference material to develop, optimize, and validate robust analytical methods according to ICH, FDA, and EMA guidelines.
• Quality Control and Assurance: Supports impurity profiling, stability testing, and batch-to-batch consistency verification in API and finished drug product manufacturing.
• Metabolite Identification and Profiling: Aids in the identification and structural elucidation of drug metabolites using mass spectrometry.
• Doping Control and Forensic Analysis: Employed as a reference compound in specialized testing laboratories for accurate substance identification.

Basic Information

Product Name	Trandolapril-D5
CAS No.	1356847-98-7
Molecular Formula	C24H29D5N2O5
Molecular Weight	431.55 g/mol
Synonyms	(2S,3aR,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydro-1H-indole-2-carboxylic acid-d5; Trandolapril-d5; Deuterated Trandolapril; Trandolapril (phenyl-d5); Mavik-d5; Gopten-d5; Odrik-d5; [2,3,4,5,6-2H5]Phenyl-Trandolapril
EINECS	Contact for details

Quality Control

Every batch of Trandolapril-D5 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data including NMR (1H, 13C) for structural confirmation and HPLC for purity assessment to ensure compliance with the highest standards for reference materials. A detailed Certificate of Analysis (COA) specifying isotopic purity, chemical purity, and residual solvent content is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Due to its hygroscopic nature, the product should be handled in a dry environment and the container kept tightly sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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