Description

5-Carboxy-6-Hydroxymethyl Dehydro Felodipine is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of cardiovascular drugs. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) derived from the felodipine class. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on developing and validating antihypertensive medications.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of advanced felodipine derivatives and related calcium channel blockers.
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in drug substance and finished product analysis.
• Impurity Profiling: Essential for method development and validation in HPLC and LC-MS to monitor and control process-related impurities and degradation products.
• Research & Development: Serves as a starting material for medicinal chemistry research aimed at creating new chemical entities with improved therapeutic profiles.
• Quality Assurance/Quality Control (QA/QC): A vital component in establishing pharmacopeial standards and ensuring batch-to-batch consistency in API manufacturing.
• Metabolite Studies: Used in pharmacokinetic and metabolic pathway research to understand drug behavior in biological systems.

Basic Information

Product Name	5-Carboxy-6-Hydroxymethyl Dehydro Felodipine
CAS No.	96558-29-1
Molecular Formula	C18H19ClNO7
Molecular Weight	396.80 g/mol
Synonyms	Dehydro Felodipine Carboxylic Acid Derivative; 5-Carboxy-6-(hydroxymethyl)-4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3-carboxylic acid; Felodipine Impurity; Felodipine Related Compound; 1,4-Dihydro-2,6-dimethyl-4-(2,3-dichlorophenyl)-5-[(hydroxymethyl)carboxy]pyridine-3-carboxylic acid; 5-Carboxy-6-hydroxymethyl-1,4-dihydro-2,6-dimethyl-4-(2,3-dichlorophenyl)-3-pyridinecarboxylic acid
EINECS	Contact for details

Quality Control

Our 5-Carboxy-6-Hydroxymethyl Dehydro Felodipine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided for full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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