Description

(S)-Amlodipine-D4 CAS NO 1346616-97-4 is a deuterated isotopologue of the active enantiomer of the widely prescribed calcium channel blocker amlodipine. This high-purity reference standard is critical for ensuring analytical accuracy and reliability in pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories for applications such as method development, validation, and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a stable, non-interfering internal standard for the precise quantification of amlodipine in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Metabolite Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioequivalence Testing: Essential for developing and validating robust analytical methods required for bioequivalence studies of generic amlodipine formulations.
• Method Development and Validation: Used as a critical tool to develop, optimize, and validate chromatographic and mass spectrometric methods according to ICH, FDA, and EMA guidelines.
• Quality Control in Manufacturing: Acts as a reference material for in-process testing and final product release testing in pharmaceutical manufacturing under GMP conditions.
• Forensic and Clinical Toxicology: Aids in the specific and sensitive detection of amlodipine in forensic investigations or therapeutic drug monitoring.

Basic Information

Product Name	(S)-Amlodipine-D4
CAS No.	1346616-97-4
Molecular Formula	C20H21D4ClN2O5
Molecular Weight	411.90 g/mol (for C20H21D4ClN2O5)
Synonyms	(S)-Amlodipine-d4; (S)-3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate-d4; Amlodipine-d4 (S-enantiomer); (S)-Amlodipine (phenyl-d4); Norvasc-d4 (S-isomer); Deuterated (S)-Amlodipine; (S)-Amlodipine (phenyl ring-d4)
EINECS	Contact for details

Quality Control

Every batch of (S)-Amlodipine-D4 is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) that detail purity, isotopic enrichment, and confirm identity and purity through orthogonal analytical techniques. Our quality commitment ensures the material meets the stringent requirements for use as a certified reference standard in 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 compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0% (Area Percent)
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D (by MS)
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.