Description

Amlodipine Maleate is a high-purity pharmaceutical salt form of the widely prescribed calcium channel blocker amlodipine. This compound is critical for the formulation of stable and bioavailable active pharmaceutical ingredients (APIs) used in cardiovascular therapeutics. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antihypertensive and antianginal medications.

Application

• Pharmaceutical API Synthesis: Key intermediate in the commercial production of amlodipine besylate and other amlodipine salt-based finished dosage forms.
• Cardiovascular Drug Formulation: Used in the development of tablets and capsules for treating hypertension (high blood pressure) and chronic stable angina.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in regulatory testing laboratories.
• Research & Development: Employed in preclinical and clinical studies to investigate pharmacokinetics, stability, and new therapeutic applications of calcium channel blockers.
• Generic Drug Manufacturing: Essential raw material for companies producing bioequivalent generic versions of branded amlodipine medications.
• Process Chemistry: Utilized in optimizing synthetic routes and scaling up production processes for cost-effective API manufacturing.

Basic Information

Product Name	Amlodipine Maleate
CAS No.	1357024-06-6
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 maleate; Amlodipine maleate salt; Amlodipine (maleate); 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester maleate salt; Norvasc maleate (related); AML maleate
EINECS	Contact for details

Quality Control

Our Amlodipine Maleate is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with typical purity levels exceeding 99.0% (by HPLC). Comprehensive testing includes identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting compliance with in-house specifications are provided with every shipment.

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 nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 99.0 %
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.2%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5 %
Heavy Metals	≤ 20 ppm

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