Description

Felodipine Metabolite Lactone is a key intermediate and reference standard in the synthesis and analytical profiling of the cardiovascular drug Felodipine. This compound is essential for pharmaceutical research and development, particularly in studies concerning drug metabolism, pharmacokinetics, and impurity characterization. It is primarily utilized by research institutions, analytical laboratories, and manufacturers in the pharmaceutical industry for method development, quality control, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Felodipine and its related substances in drug products and biological matrices.
• Metabolite Research: Serves as a critical standard in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to understand the metabolic pathways of Felodipine.
• Impurity Profiling: Employed in the development and validation of analytical methods (e.g., HPLC, LC-MS) to monitor and control process-related impurities and degradation products.
• Chemical Synthesis: Acts as a high-purity intermediate or starting material for the synthesis of Felodipine and its structural analogs in process chemistry.
• Quality Control & Assurance: Integral for ensuring batch-to-batch consistency and compliance with pharmacopoeial standards (e.g., USP, EP) in active pharmaceutical ingredient (API) manufacturing.
• Bioanalytical Studies: Utilized in the calibration of assays for detecting and measuring Felodipine metabolites in clinical and preclinical studies.

Basic Information

Product Name	Felodipine Metabolite Lactone
CAS No.	85825-42-9
Molecular Formula	C18H19Cl2NO4
Molecular Weight	384.26 g/mol
Synonyms	Felodipine Lactone; Felodipine Impurity C; 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester Lactone; 3-Ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate Lactone; Felodipine Related Compound C; Dehydro Felodipine Lactone; Felodipine Degradation Product
EINECS	Contact for details

Quality Control

Our Felodipine Metabolite Lactone is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure containers are sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.