Description

Amlodipine Maleate is a pharmaceutically active salt form of the widely prescribed calcium channel blocker, amlodipine. This compound is a critical intermediate in the synthesis of finished dosage forms for cardiovascular therapeutics, offering enhanced stability and processing characteristics. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of antihypertensive and antianginal medications.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Key starting material for the synthesis of amlodipine besylate, the active ingredient in medications for hypertension and angina.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies for developing new cardiovascular drug formulations and delivery systems.
• Generic Drug Manufacturing: Essential for companies producing generic versions of amlodipine-based medications, ensuring cost-effective supply chains.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in pharmaceutical labs.
• Chemical Synthesis: Employed in organic synthesis for creating novel amlodipine derivatives and related chemical entities for pharmacological evaluation.

Basic Information

Product Name	Amlodipine Maleate
CAS No.	88150-47-4
Molecular Formula	C26H31ClN2O8
Molecular Weight	535.0 g/mol
Synonyms	Amlodipine maleate salt; 3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate maleate; Amlodipine hydrogen maleate; Amlodipine (maleate); Norvasc intermediate; AML maleate; 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester maleate (1:1)
EINECS	Contact for details

Quality Control

Our Amlodipine Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide Certificates of Analysis (COA) with each shipment, detailing key parameters such as assay, related substances, and residual solvents. Our quality commitment aligns with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for API intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0%
Heavy Metals	≤ 20 ppm

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