Description

(S)Lisinopril-D5 is a high-purity, isotopically labeled deuterated analog of the widely prescribed antihypertensive drug Lisinopril. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, clinical research organizations, and analytical service providers engaged in drug development and therapeutic monitoring.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of Lisinopril in biological matrices (plasma, serum, urine) using Liquid Chromatography-Tandem Mass Spectrometry.
• Pharmacokinetic & Bioequivalence Studies: Critical for generating reliable data on drug absorption, distribution, metabolism, and excretion (ADME) in clinical trials.
• Metabolite Profiling & Identification: Aids in the detection and structural elucidation of Lisinopril metabolites, supporting drug safety and efficacy evaluations.
• Method Development & Validation: Used to establish, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines (e.g., ICH Q2(R1)).
• Therapeutic Drug Monitoring (TDM): Enables accurate measurement of Lisinopril concentrations in patient samples to optimize dosage and ensure therapeutic efficacy.
• Quality Control in Pharmaceutical Analysis: Supports in-process control and final product testing in manufacturing environments requiring high analytical precision.

Basic Information

Product Name	(S)Lisinopril-D5
CAS No.	1356905-39-9
Molecular Formula	C21H26D5N3O5•2H2O
Molecular Weight	441.55 g/mol (Dihydrate)
Synonyms	Lisinopril-d5; Deuterated Lisinopril; (2S)-1-[(2S)-6-Amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid-d5; N2-[(S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline-d5; Zestril-d5; Prinivil-d5; MK-521-d5; Isotopic Labeled Lisinopril
EINECS	Contact for details

Quality Control

Our (S)Lisinopril-D5 is manufactured under strict quality systems to ensure batch-to-batch consistency and high isotopic purity. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing key parameters such as chemical purity, isotopic enrichment, and absence of interfering impurities. We adhere to standards relevant for analytical reference materials, supporting compliance with ICH, GLP, and GMP guidelines for pharmaceutical analysis.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 8.0%
Residue on Ignition	≤ 0.1%

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