Amlodipine, identified by its CAS number 88150-42-9, stands as a critical Active Pharmaceutical Ingredient (API) widely utilized in the management of cardiovascular diseases, primarily hypertension and angina. As a crucial raw material in powder form, high-quality Amlodipine is indispensable for pharmaceutical manufacturers globally. Its efficacy stems from its action as a dihydropyridine calcium channel blocker, which inhibits the influx of calcium ions into vascular smooth muscle and myocardial cells. This inhibition results in vasodilation and reduced peripheral vascular resistance, leading to a decrease in blood pressure.

The therapeutic applications of Amlodipine are well-established. It is effectively used either alone or in combination with other antihypertensive agents to treat hypertension. For patients suffering from chronic stable angina or vasospastic angina, Amlodipine offers significant relief by increasing myocardial oxygen supply, particularly in cases of coronary artery spasm. Its versatility and established safety profile make it a preferred choice in cardiovascular therapy.

The physical characteristics of Amlodipine Powder are important for its processing and formulation. It is typically a light yellow crystalline powder with a molecular formula of C20H25ClN2O5 and a molecular weight of approximately 408.88. The material provided adheres to stringent purity specifications, often meeting standards of 98% or higher, critical for its use as an API. Its density is approximately 1.227. Proper storage conditions are paramount to maintain the stability and potency of the powder; it should be sealed and stored in a cool, dry place, protected from light and moisture. Packaging typically involves materials like aluminium foil bags and cartons, ensuring product integrity during transport and storage.

Ensuring the quality and purity of Amlodipine API is non-negotiable for pharmaceutical companies. Manufacturers rigorously test the material to confirm it meets pharmacopoeial standards such as USP (United States Pharmacopeia), BP (British Pharmacopoeia), and EP (European Pharmacopoeia). Adherence to Good Manufacturing Practices (GMP) is fundamental throughout the production process, ensuring consistency, quality, and traceability. Certifications like ISO 9001 and adherence to HSE (Health, Safety, Environment) standards further demonstrate a commitment to quality and responsible production.

The production of Amlodipine involves complex chemical synthesis steps, starting from specific precursors. Each stage of the manufacturing process must be carefully controlled and monitored to prevent impurities and ensure high yield and purity. Advanced analytical techniques, such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and spectroscopic methods, are employed for quality control testing at various stages, including testing of raw materials, intermediates, and the final API product. Impurity profiling is a critical aspect, ensuring that potential harmful by-products are below regulatory limits. Moisture content, particle size distribution, and polymorph form are also carefully controlled as they can impact the API's processability and bioavailability in final dosage forms.

Regulatory compliance is another significant factor in the Amlodipine API market. Manufacturers must navigate complex regulatory landscapes, including obtaining Drug Master Files (DMFs) or similar documentation in various countries to support their customers' drug product registrations. This involves providing detailed information about the manufacturing process, quality control, stability data, and packaging. Reliable suppliers invest heavily in regulatory affairs expertise to facilitate the market entry of their customers' finished drug products containing Amlodipine.

The global demand for Amlodipine API remains strong due to the increasing prevalence of hypertension and cardiovascular diseases worldwide. As a widely prescribed and effective medication, the need for a consistent and reliable supply of high-quality Amlodipine powder is constant. Pharmaceutical companies formulating tablets or capsules depend on API manufacturers who can provide material that meets the strictest international standards.

For pharmaceutical companies seeking a dependable source of high-quality Amlodipine Powder CAS 88150-42-9, finding a reputable API manufacturer is crucial. When looking to buy Amlodipine Powder, factors such as purity, compliance with GMP and pharmacopoeial standards (USP, BP), regulatory support (DMF availability), production capacity, and competitive price are key considerations. As a dedicated Amlodipine manufacturer and supplier, NINGBO INNO PHARMCHEM CO.,LTD. is committed to providing API that meets these rigorous requirements. Pharmaceutical businesses can confidently purchase Amlodipine API, ensuring the quality and efficacy of their final drug products. Information regarding specific product details, purity levels, packaging options, and current price quotes can be obtained directly, facilitating a smooth and efficient purchase process for this essential pharmaceutical raw material.