Description

Enalapril-D5 tert-Butyl Ester is a high-purity, deuterium-labeled internal standard critical for precise quantitative analysis in pharmaceutical research and development. This stable isotope-labeled compound is essential for ensuring the accuracy and reliability of mass spectrometry-based methods, particularly in pharmacokinetic and bioanalytical studies. It is primarily utilized by analytical laboratories, CROs, and pharmaceutical companies engaged in the development and quality control of cardiovascular medications.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the accurate quantification of Enalapril and its metabolites in complex biological matrices like plasma and serum.
• Pharmaceutical R&D: Enables precise drug metabolism and pharmacokinetics (DMPK) studies during the development of ACE inhibitor therapies.
• Bioanalytical Method Development: Used to validate and optimize high-performance liquid chromatography (HPLC) and tandem mass spectrometry methods for improved sensitivity and specificity.
• Clinical Research: Supports therapeutic drug monitoring and bioavailability/bioequivalence studies in clinical trials.
• Metabolite Identification: Aids in the structural elucidation and tracking of drug metabolites in in vitro and in vivo studies.
• Quality Control & Assurance: Employed in GMP/GLP environments to ensure batch-to-batch consistency and purity of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Enalapril-D5 tert-Butyl Ester
CAS No.	1356837-84-7
Molecular Formula	C20H23D5N2O5
Molecular Weight	~377.48 g/mol
Synonyms	(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline tert-Butyl Ester-d5; Enalapril tert-Butyl Ester-d5; Enalapril-d5 t-Butyl Ester; MK-421-d5 tert-Butyl Ester; Deuterated Enalapril tert-Butyl Ester; Enalapril Internal Standard-d5; (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid tert-butyl ester-d5
EINECS	Contact for details

Quality Control

Our Enalapril-D5 tert-Butyl Ester is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and research documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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