Description

Amlodipine-D4 is a high-purity, deuterium-labeled internal standard critical for ensuring analytical accuracy and reliability in quantitative bioanalysis. This stable isotope-labeled compound is essential for researchers and quality control laboratories requiring precise measurement of amlodipine in complex matrices. It is primarily used in the pharmaceutical and contract research organization (CRO) sectors for method development, pharmacokinetic studies, and regulatory compliance testing.

Application

• LC-MS/MS Internal Standard: Serves as a critical reference compound for the accurate quantification of amlodipine in biological fluids (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic & Bioequivalence Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Method Development & Validation: Used as a deuterated standard to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Drug Metabolism Research: Facilitates the study of amlodipine's metabolic pathways and the identification of its metabolites.
• Quality Control in Pharmaceutical Manufacturing: Employed in in-process testing and final product release to ensure the potency and consistency of amlodipine-based drug formulations.
• Forensic & Anti-Doping Analysis: Supports the accurate detection and quantification of amlodipine in forensic toxicology and sports doping control.

Basic Information

Product Name	Amlodipine-D4
CAS No.	1185246-14-3
Molecular Formula	C20H21D4ClN2O5
Molecular Weight	~413.90 g/mol
Synonyms	3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate-d4; Deuterated Amlodipine; Amlodipine (phenyl-d4); Amlodipine-d4 (major); 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester-d4; (RS)-Amlodipine-d4; Norvasc-d4 (labeled)
EINECS	Contact for details

Quality Control

Every batch of Amlodipine-D4 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support your research and regulatory submissions, including proof of structure and isotopic purity. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting key parameters such as chemical purity, isotopic enrichment, and chromatographic profile. Our quality commitment aligns with the standards expected for high-value reference materials in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

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 (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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