Description

Amlodipine Mesylate is the mesylate salt form of the widely used calcium channel blocker, amlodipine. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the consistent efficacy and stability of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of cardiovascular medications. The compound is supplied as Amlodipine Mesylate CAS NO 246852-12-0, meeting stringent quality standards for industrial and research use.

Application

• Primary Pharmaceutical Ingredient: As the active salt in the formulation of anti-hypertensive and anti-anginal drugs.
• Finished Dosage Form Manufacturing: For the production of tablets, capsules, and other solid oral dosage forms containing amlodipine.
• Research & Development: Serving as a key reference standard and starting material in preclinical and clinical studies for new cardiovascular therapies.
• Analytical Testing: Used as a certified reference material in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.
• Process Development: Utilized in pharmaceutical process chemistry for optimizing synthesis, purification, and scale-up operations.
• Generic Drug Production: A vital component for manufacturers producing bioequivalent versions of branded amlodipine medications.

Basic Information

Product Name	Amlodipine Mesylate
CAS No.	246852-12-0
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	Amlodipine Methanesulfonate; 3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate methanesulfonate; Amlodipine Mesilate; Amlodipine Mesylate Salt; Norvasc Mesylate; Amlodipine Monomethanesulfonate; (RS)-Amlodipine Mesylate
EINECS	Contact for details

Quality Control

Our Amlodipine Mesylate is manufactured and tested under a strict quality management system. Each batch is analyzed to ensure it meets high-purity standards suitable for pharmaceutical applications, with typical purity exceeding 99.0%. Certificates of Analysis (COA) are provided with each shipment, detailing results for identity, assay, related substances, residual solvents, and other pharmacopeial parameters. We adhere to cGMP principles where applicable to ensure supply reliability and batch-to-batch consistency for our global customers.

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 (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	99.0% - 101.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 0.5% Any single impurity ≤ 0.2%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets 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.