Description

(R)-(+)-Felodipine-D5 is a high-purity, deuterium-labeled isotopologue of the calcium channel blocker felodipine, specifically designed for use as an internal standard in quantitative analytical methods. This compound is essential for ensuring the accuracy and reliability of pharmacokinetic and bioanalytical studies by correcting for variations in sample preparation and instrument response. It is a critical tool for pharmaceutical researchers, analytical chemists, and contract research organizations (CROs) engaged in drug metabolism, bioavailability testing, and clinical trial support.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application as a stable, non-interfering reference compound for the precise quantification of felodipine in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Bioequivalence Studies: Enables accurate measurement of drug concentration over time, critical for determining absorption, distribution, metabolism, and excretion (ADME) profiles.
• Drug Metabolism Research (DMPK): Used in in vitro and in vivo studies to track the parent drug and differentiate it from metabolites, facilitating metabolic pathway elucidation.
• Clinical Trial Support: Ensures data integrity in therapeutic drug monitoring and compliance testing during clinical phases of cardiovascular drug development.
• Method Development and Validation: Serves as a key component in establishing robust, regulatory-compliant (FDA, EMA) bioanalytical methods for GLP and GCP environments.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability-indicating assays for felodipine-based drug products.

Basic Information

Product Name	(R)-(+)-Felodipine-D5
CAS No.	1217744-87-0
Molecular Formula	C18H14D5Cl2NO4
Molecular Weight	384.27 g/mol (for deuterated form)
Synonyms	(R)-4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid ethyl methyl ester-D5; (R)-(+)-Felodipine-d5; Felodipine (R-enantiomer)-D5; Deuterated (R)-Felodipine; Felodipine-D5 (R-isomer); (R)-Felodipine (pentadeuterated); 3,5-Pyridinedicarboxylic acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, 3-ethyl 5-methyl ester, (R)-, labeled with deuterium
EINECS	Contact for details

Quality Control

Every batch of (R)-(+)-Felodipine-D5 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, isotopic purity, and chemical purity assessments. Certificates of Analysis (COA) detailing batch-specific results from HPLC, NMR, and MS are 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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 atom % D
Chemical Purity (NMR)	Conforms
Specific Rotation	Contact for details
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.