Amlodipine Besilate – High-quality Active Pharmaceutical Ingredient (API) for cardiovascular and hypertension treatment

1. General introduction to Amlodipine Besilate

Amlodipine Besilate is a highly effective and widely prescribed Active Pharmaceutical Ingredient (API) belonging to the dihydropyridine class of calcium channel blockers. It acts by inhibiting the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This is the core material widely applied in pharmaceutical formulations for the treatment of hypertension (high blood pressure) and coronary artery disease, including chronic stable angina and vasospastic angina (Prinzmetal's or variant angina). With high purity, excellent bioavailability, and a gradual onset of action, Amlodipine Besilate helps maintain stable long-term blood pressure without causing reflex tachycardia, ensuring consistent quality and therapeutic efficacy for finished pharmaceutical products globally.

2. Information about Amlodipine Besilate raw material

• Material name: Amlodipine Besilate
• Material group: Active Pharmaceutical Ingredient (API) / Calcium channel blocker.
• Function: Treatment of hypertension, chronic stable angina, and vasospastic angina.
• Chemical composition: C20H25ClN2O5·C6H6O3S
• Molecular weight: 567.1 g/mol
• Material form: White or almost white crystalline powder, free from visible foreign particles.
• Solubility: Slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol.

3. Advantages of the material

• High clinical efficacy and pharmacokinetic profile: Provides prolonged vasodilation and a long elimination half-life (approximately 30 to 50 hours), helping to stabilize blood pressure over 24 hours with a single, convenient daily dose.
• Optimal purity and safety: Impurity levels, including heavy metals and residual solvents, are strictly controlled below allowable international limits, ensuring maximum safety and tolerability for patients undergoing long-term therapy.
• Good physicochemical stability: Exhibits excellent stability under various temperature and humidity conditions. It is perfectly compatible with common pharmaceutical excipients (such as microcrystalline cellulose and magnesium stearate), which is highly convenient during direct compression, tableting, or capsule filling processes.
• Cardioprotective properties: By reducing peripheral vascular resistance (afterload) and dilating coronary arteries, it significantly decreases the workload of the heart and myocardial oxygen demand.

4. Applications of Amlodipine Besilate

In pharmaceuticals (Core application): Manufacturing of oral solid dosage forms, primarily tablets and hard gelatin capsules. It is the largest and most critical application, used as the main Active Pharmaceutical Ingredient (API) in monotherapy or combination therapies (e.g., with ACE inhibitors, ARBs like Valsartan, or statins like Atorvastatin) for antihypertensive and anti-anginal drugs, serving the comprehensive treatment and management of severe cardiovascular diseases.

5. Commercial products using Amlodipine Besilate

6. Product contact information

• Consultation Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website: www.biorichgroup.com
• Sample/COA Request: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) of the material.