Description

Amlodipine Benzoate is a benzoate salt form of the widely prescribed calcium channel blocker amlodipine, offering enhanced stability and handling properties for pharmaceutical manufacturing. This high-purity intermediate is critical for ensuring the consistent quality, efficacy, and safety of final drug formulations. It is primarily required by pharmaceutical companies and advanced research institutions engaged in the development and production of cardiovascular medications, particularly antihypertensive and antianginal drugs.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Key synthetic precursor in the commercial production of amlodipine besylate, the active ingredient in blockbuster cardiovascular drugs.
• Pharmaceutical Research & Development: Used in analytical method development, stability studies, and the synthesis of novel amlodipine derivatives or prodrugs.
• Reference Standard: Serves as a certified reference material (CRM) for quality control laboratories to identify and quantify impurities or related substances via HPLC or LC-MS.
• Formulation Studies: Employed in pre-formulation research to study salt selection, polymorphism, and compatibility with various excipients.
• Generic Drug Manufacturing: Essential raw material for companies producing bioequivalent generic versions of amlodipine-based medications.

Basic Information

Product Name	Amlodipine Benzoate
CAS No.	1239916-29-0
Molecular Formula	C26H31ClN2O8
Molecular Weight	535.0 g/mol
Synonyms	3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzoate; Amlodipine benzoate salt; Benzoic acid, compd. with (4R,S)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine (1:1); Amlodipine monobenzoate
EINECS	Contact for details

Quality Control

Our Amlodipine Benzoate is manufactured under strict quality management systems, with purity and identity verified against stringent in-house specifications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters. We adhere to cGMP principles where applicable, ensuring traceability and consistency for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5%
Single Maximum Impurity	≤0.5%
Loss on Drying	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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