Description

Amlodipine Besylate CAS NO 111470-99-6 is a high-purity pharmaceutical active ingredient, specifically the besylate salt form of the widely prescribed calcium channel blocker amlodipine. This compound is critical for the formulation of safe and effective antihypertensive and antianginal medications. It is an essential raw material for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug production.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of finished dosage forms for hypertension and angina pectoris treatment.
• Reference Standard for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Research Chemical for preclinical and clinical studies investigating cardiovascular pharmacology and new therapeutic applications.
• Generic Drug Formulation as a key component in bioequivalent generic versions of branded amlodipine medications.
• Pharmaceutical Intermediates for further chemical synthesis or salt formation processes in advanced drug manufacturing.

Basic Information

Product Name	Amlodipine Besylate
CAS No.	111470-99-6
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	Amlodipine Besilate; Amlodipine Benzenesulfonate; 3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate; Norvasc (Brand Name Salt); Amlodipine Besylate USP; Amlodipine Besylate EP; AML-B
EINECS	Contact for details

Quality Control

Our Amlodipine Besylate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities. A Certificate of Analysis (COA) detailing all test results is provided to ensure full traceability and compliance with cGMP guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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