Description

Enalapril-D5 Maleate Salt is a high-purity, stable isotope-labeled analog of the widely prescribed antihypertensive drug, enalapril. This deuterated compound is an essential internal standard for the precise and accurate quantification of enalapril in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical research laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research. The product ensures reliable data integrity and method validation in regulated environments.

Application

• Internal Standard for LC-MS/MS Analysis: Critical for the quantitative bioanalysis of enalapril in plasma, serum, and urine samples.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioequivalence Testing: Used as a reference standard in studies comparing generic and brand-name formulations of enalapril.
• Method Development and Validation: Serves as a key component in establishing and validating robust analytical methods per FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay verification of active pharmaceutical ingredients (APIs).
• Stable Isotope Dilution Mass Spectrometry: Employed in high-accuracy quantification to correct for matrix effects and instrument variability.

Basic Information

Product Name	Enalapril-D5 Maleate Salt
CAS No.	349554-02-5
Molecular Formula	C20H23D5N2O5 • C4H4O4
Molecular Weight	~ 534.58 g/mol
Synonyms	(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-D5-alanyl]-L-proline Maleate Salt; Enalapril-d5 Maleate; Enalapril (phenyl-d5) Maleate Salt; Deuterated Enalapril Maleate; MK-421-d5; Vasotec-d5; (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl-d5]amino]propanoyl]pyrrolidine-2-carboxylic acid ethyl ester maleate salt
EINECS	Contact for details

Quality Control

Our Enalapril-D5 Maleate Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including NMR, HPLC, and mass spectrometry, to confirm isotopic purity, chemical purity, and identity. We provide comprehensive Certificates of Analysis (COA) detailing all test results, ensuring compliance with the stringent requirements of analytical and pharmaceutical research. The product is suitable for use in GLP and GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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