Description

(±)-Felodipine-D3 (2,3-Dichlorophenyl-D3) is a deuterium-labeled analog of the calcium channel blocker felodipine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies, where precise measurement of the parent drug is required. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies conducting drug metabolism and stability testing.

Application

• Internal Standard for LC-MS/MS: Primary use as a stable isotope-labeled internal standard for the accurate quantification of felodipine in biological matrices (plasma, serum, urine) and pharmaceutical formulations via liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise tracking of felodipine absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, validating, and transferring robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Pharmaceutical Quality Control: Used in impurity profiling and assay development for felodipine-based drug products to ensure batch-to-batch consistency and purity.
• Stability-Indicating Assays: Facilitates the study of felodipine degradation pathways and the stability of drug products under various stress conditions.
• Forensic and Clinical Toxicology: Supports accurate measurement of felodipine levels in cases of overdose or therapeutic drug monitoring.

Basic Information

Product Name	(±)-Felodipine-D3 (2,3-Dichlorophenyl-D3)
CAS No.	1219795-30-8
Molecular Formula	C18H16D3Cl2NO4
Molecular Weight	~387.27 g/mol
Synonyms	Felodipine-d3; Felodipine (phenyl-d3); 4-(2,3-Dichlorophenyl-d3)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid ethyl methyl ester; 3-Ethyl 5-methyl 4-(2,3-dichlorophenyl-d3)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate; Deuterated Felodipine; Felodipine Internal Standard; [2H3]-Felodipine
EINECS	Contact for details

Quality Control

Every batch of (±)-Felodipine-D3 (2,3-Dichlorophenyl-D3) is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting demands of quantitative bioanalysis. Our products undergo rigorous quality testing, including NMR and mass spectrometry for isotopic enrichment verification and HPLC for chemical purity assessment. Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

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 compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent degradation.

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 (Deuterium Enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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