Description

Dehydro Felodipine-D3 is a deuterium-labeled analog of a key felodipine metabolite, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity reference material is essential for ensuring the accuracy and reliability of mass spectrometry-based assays in pharmaceutical research and development. It is primarily utilized by scientists and quality control laboratories in the pharmaceutical, contract research organization (CRO), and academic sectors for pharmacokinetic studies, drug metabolism research, and method validation.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of felodipine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used to investigate metabolic pathways and the formation of dehydro felodipine in vitro and in vivo.
• Method Development and Validation: Serves as a stable isotope-labeled standard to establish robust, sensitive, and specific analytical methods compliant with FDA and ICH guidelines.
• Clinical Trial Support: Provides reliable data for patient sample analysis during various phases of clinical trials for cardiovascular drugs.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and stability testing of felodipine-based drug products.

Basic Information

Product Name	Dehydro Felodipine-D3
CAS No.	1189916-52-6
Molecular Formula	C18H16D3Cl2NO4
Molecular Weight	~384.28 g/mol
Synonyms	Dehydro Felodipine-d3; Felodipine Impurity D-d3; 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester-d3 (Dehydro); Deuterated Dehydro Felodipine; [2H3]-Dehydro Felodipine; Isotopically Labeled Felodipine Metabolite; IS for Felodipine Assay
EINECS	Contact for details

Quality Control

Every batch of Dehydro Felodipine-D3 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments. Our standard quality commitment includes high chemical and isotopic purity, verified by advanced techniques like NMR (1H, 13C) and mass spectrometry. A detailed Certificate of Analysis (COA) is supplied with each product, listing batch-specific results for identity, purity, and isotopic enrichment. Specifications are designed to meet the rigorous demands of bioanalytical method validation per ICH M10 and related guidelines.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Allow the container to reach room temperature in a dry environment before opening to minimize moisture condensation. The product should be stored in a dedicated freezer away from strong acids and bases.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
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.