Description

(S)-Amlodipine-D4 CAS NO 1346617-19-3 is a high-purity, deuterium-labeled internal standard of the widely prescribed calcium channel blocker amlodipine. This stable isotope-labeled compound is critical for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies requiring precise and compliant analytical data.

Application

• Bioanalytical Method Development and Validation: Serves as a primary internal standard for the quantification of amlodipine in biological matrices (plasma, serum, urine) using LC-MS/MS and GC-MS.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and preclinical research.
• Drug Metabolism and Metabolite Identification: Used in mass spectrometry to differentiate drug-derived metabolites from endogenous compounds, facilitating metabolic pathway elucidation.
• Quality Control and Impurity Profiling: Supports the analysis of amlodipine drug substances and finished pharmaceutical products for purity and stability testing.
• Forensic and Doping Control Analysis: Provides a reliable reference for the confirmatory analysis of amlodipine in forensic toxicology and anti-doping programs.
• Regulatory Submission Support: Generates the high-quality data required for regulatory filings with agencies like the FDA, EMA, and PMDA.

Basic Information

Product Name	(S)-Amlodipine-D4
CAS No.	1346617-19-3
Molecular Formula	C20H21D4ClN2O5
Molecular Weight	411.90 g/mol
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); Deuterated (S)-Amlodipine; (S)-Amlodipine (phenyl-d4); Amlodipine (phenyl-d4) S-isomer; Norvasc-d4 (S-enantiomer); AML-d4 (S)
EINECS	Contact for details

Quality Control

Every batch of (S)-Amlodipine-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing identity, purity (by HPLC), isotopic enrichment, and impurity profiles to ensure compliance with the stringent requirements of analytical reference standard applications. Our quality commitment supports GMP/GLP-aligned workflows for pharmaceutical development.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 atom % D
Chemical Purity	≥95%
Specific Optical Rotation	Contact for details
Residual Solvents (GC)	Complies with ICH limits

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