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Amlodipine Besilate is a long-acting dihydropyridine calcium channel blocker widely used in the treatment of hypertension, chronic stable angina, and vasospastic angina. It works by inhibiting calcium ion influx into vascular smooth muscle and cardiac muscle, resulting in vasodilation, reduced peripheral resistance, and lower blood pressure.
At Bluepill Express, we manufacture and export high-purity Amlodipine Besilate API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API ensures consistent pharmacological performance, high assay purity (≥99%), and low impurity levels, making it ideal for oral dosage formulations including tablets and combination therapies.
Amlodipine Besilate is widely supplied for cardiovascular therapy formulations and is trusted in global markets for its long half-life, excellent stability, and bioavailability.
Therapeutic Applications:
- Hypertension management (primary and secondary)
- Chronic stable angina
- Vasospastic (Prinzmetal’s) angina
- Prevention of cardiovascular complications associated with high blood pressure
Mechanism of Action:
Amlodipine blocks L-type calcium channels in vascular smooth muscle and myocardium, leading to relaxation of peripheral arteries, decreased vascular resistance, and improved myocardial oxygen delivery. This reduces blood pressure and alleviates angina symptoms without significant negative effects on heart rate.
Technical Specifications:
- Chemical Name: 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate besilate
- Molecular Formula: C₂₀H₂₅ClN₂O₅·C₆H₆O₃S
- Molecular Weight: 567.1 g/mol
- CAS Number: 111470-99-6
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Solubility: Freely soluble in methanol; slightly soluble in water
- Storage Conditions: Store below 25°C, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Calcium Channel Blocker / Antihypertensive / Antianginal
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral tablets (2.5 mg, 5 mg, 10 mg)
- Combination tablets with beta-blockers, ARBs, or diuretics
Manufacturing & Quality Standards – Bluepill Express:
- Produced in WHO-GMP and cGMP certified facilities
- High assay API (≥99%) with consistent quality and particle size
- Analytical testing by HPLC, NMR, and FTIR for identity and purity
- Low residual solvents and impurities according to ICH guidelines
- Full documentation support: COA, MSDS, DMF available for regulatory submission
- Batch-to-batch reproducibility for formulation consistency
Advantages of Bluepill Express Amlodipine Besilate API:
- High chemical stability with long shelf-life
- Pharmacopeial grade compliance (IP/BP/USP/EP)
- DMF-ready documentation for international markets
- Optimized particle size for smooth tablet compression and dissolution
- Reliable supply chain for global pharmaceutical export
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liners
- Shelf Life: 3 years under recommended storage conditions
- Labeling: Compliant with international pharmacopeial and export standards
- Export Markets: Europe, Latin America, Middle East, Africa, and Asia-Pacific
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability and Validation Reports
