Description

2-Carboxybenzoyl Amlodipine is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of Amlodipine, a widely prescribed calcium channel blocker. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, process optimization, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Amlodipine besylate and other Amlodipine salts.
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Amlodipine API and finished dosage forms.
• Impurity Profiling: Essential for method development and validation in HPLC and LC-MS analysis to monitor process-related impurities.
• Research & Development: Serves as a starting material or reagent in medicinal chemistry research for developing new cardiovascular drug candidates.
• Quality Assurance/Quality Control (QA/QC): Employed in in-house laboratory testing to ensure batch-to-batch consistency and compliance with pharmacopoeial standards (USP, EP).
• Regulatory Submissions: Provides necessary data on specified impurities for drug master files (DMFs) and new drug applications (NDAs).

Basic Information

Product Name	2-Carboxybenzoyl Amlodipine
CAS No.	318465-73-5
Molecular Formula	C26H28ClN2O8
Molecular Weight	531.96 g/mol
Synonyms	2-Carboxybenzoyl Amlodipine; Amlodipine Impurity F (EP); Amlodipine Related Compound F (USP); 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-((2-Carboxybenzoyl)amino)ethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Carboxybenzoyl Impurity; 2-[(2-{[(2-Carboxybenzoyl)amino]ethoxy}methyl)-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine; Amlodipine 2-Carboxybenzoyl Derivative
EINECS	Contact for details

Quality Control

Our 2-Carboxybenzoyl Amlodipine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identification by IR and NMR spectroscopy, and control of specified impurities. We provide full traceability and support regulatory requirements with comprehensive documentation. A detailed Certificate of Analysis (COA) is supplied with every shipment, confirming compliance with in-house specifications aligned with pharmacopoeial guidelines.

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 dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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.