Amlodipine Sulfate (CAS 111470-99-6) – Complete Pharmaceutical Guide

Introduction to Amlodipine Sulfate

What is Amlodipine Sulfate?

In the world of cardiovascular medicines, Amlodipine Sulfate (CAS 111470-99-6) represents an important variation of a widely trusted drug. If you’ve been working in pharmaceutical manufacturing or sourcing APIs, you already know how critical salt forms are. They directly impact drug stability, solubility, and overall performance—and that’s exactly where Amlodipine Sulfate comes into play.

Amlodipine-Sulfate-CAS-111470-99-6-Complete-Pharmaceutical-Guide
Amlodipine-Sulfate-CAS-111470-99-6-Complete-Pharmaceutical-Guide

.Amlodipine Sulfate is a salt form of amlodipine, a well-established calcium channel blocker used to treat hypertension and angina. Its primary function is to relax blood vessels, allowing smoother blood flow and reducing blood pressure. This helps decrease strain on the heart and improves cardiovascular efficiency.

What makes this variant interesting is its potential in formulation flexibility. Pharmaceutical companies are constantly exploring salt forms like sulfate to optimize drug delivery and manufacturing efficiency. With increasing demand for cardiovascular medications worldwide, Amlodipine Sulfate is gaining attention as a viable API option.

CAS Number and Chemical Identity

The CAS Number 111470-99-6 uniquely identifies Amlodipine Sulfate in chemical and pharmaceutical databases. This ensures consistency across global markets, making sourcing, regulatory filing, and documentation seamless.

Chemically, Amlodipine Sulfate is formed by reacting amlodipine with sulfuric acid, creating a stable salt. This transformation enhances certain pharmaceutical properties such as solubility and chemical robustness, which are critical for large-scale production and long-term storage.

Chemical and Physical Properties

Molecular Structure and Formula

The molecular structure of Amlodipine Sulfate is specifically designed to interact with calcium channels in vascular smooth muscles. Its structure allows selective binding, ensuring targeted therapeutic action while minimizing side effects.

From a manufacturing perspective, this structural stability is highly valuable. It ensures that the API maintains its integrity during formulation, packaging, and distribution. This consistency directly impacts the quality and effectiveness of the final pharmaceutical product.

Physical Characteristics and Solubility

Amlodipine Sulfate is typically found as a white to off-white crystalline powder, which is easy to process in pharmaceutical manufacturing. Its solubility characteristics support efficient drug absorption, ensuring reliable therapeutic outcomes.

This combination of physical and chemical stability makes it a practical choice for tablet and capsule formulations.

Mechanism of Action

Role in Calcium Channel Blocking

Let’s break it down simply. Calcium ions play a major role in muscle contraction, including the muscles in blood vessels. When these muscles contract, blood pressure rises. Amlodipine Sulfate blocks calcium entry into these cells, causing the vessels to relax.

This relaxation reduces vascular resistance and helps maintain normal blood pressure levels without causing sudden fluctuations.

Impact on Blood Pressure Regulation

Amlodipine Sulfate provides a long-lasting antihypertensive effect, making it ideal for once-daily dosing. It ensures steady blood pressure control, which is crucial for preventing complications like stroke, heart attack, and kidney damage.

Patients benefit from improved circulation and reduced cardiovascular risk, making it a cornerstone in hypertension management.

Medical Uses and Applications

Treatment of Hypertension

Hypertension is one of the most common chronic diseases globally, and Amlodipine Sulfate plays a key role in its management. Its effectiveness, safety profile, and long duration of action make it a preferred choice for healthcare providers.

It is often used both as a standalone therapy and in combination with other antihypertensive drugs.

Angina and Cardiovascular Benefits

Amlodipine Sulfate is also widely used for treating angina, helping improve oxygen supply to the heart. By dilating coronary arteries, it reduces chest pain and enhances heart function.

Its dual therapeutic benefits make it highly valuable in cardiovascular drug formulations.

Market Demand and Industry Trends

Global Demand for Amlodipine API

The global pharmaceutical market continues to see strong demand for Amlodipine-based APIs. With cardiovascular diseases being a leading cause of mortality worldwide, the need for effective antihypertensive drugs is continuously increasing.

Growth in Emerging Markets

Emerging economies are driving much of this demand. Increased healthcare awareness, better access to medicines, and government health initiatives are contributing to the growth of Amlodipine Sulfate usage.

Manufacturing Process Overview

Raw Materials and Synthesis

The synthesis of Amlodipine Sulfate involves controlled chemical reactions using high-quality raw materials. Precision in the manufacturing process is essential to ensure consistency and purity.

Quality Control and Compliance

Strict quality control measures are followed to ensure the API meets international standards. Analytical techniques like HPLC are used to confirm purity, potency, and compliance.

Regulatory Standards and Certifications

IP, BP, USP Standards

Amlodipine Sulfate must meet pharmacopoeial standards such as IP, BP, and USP, ensuring its quality and safety for pharmaceutical use.

WHO-GMP and FDA Compliance

Manufacturers are required to follow WHO-GMP guidelines and relevant FDA regulations to ensure global acceptance and regulatory compliance.

Packaging, Storage, and Stability

Storage Conditions

The API should be stored in a cool, dry place, protected from light and moisture to maintain its stability.

Shelf Life and Handling

Proper storage conditions ensure a long shelf life. Careful handling during transportation and storage is essential to preserve product quality.

Comparison with Other Amlodipine Salts

Feature

Sulfate

Besylate

    Maleate

    Mesylate

Stability

    High

    Very High

    High

    High

Solubility

    Good

    Excellent

    Moderate

    Good

Cost

    Competitive

    Higher

    Moderate

    Competitive

Usage

    Emerging

    Widely Used

    Emerging

    Growing

Advantages of Sulfate Form

Amlodipine Sulfate offers a balanced profile of stability, solubility, and cost, making it a promising option for pharmaceutical manufacturers looking to diversify formulations.

Supplier Selection Guide

Key Factors to Consider

When selecting a supplier, factors like regulatory compliance, product consistency, pricing, and documentation should be carefully evaluated.

Importance of Reliable Manufacturers

A reliable supplier ensures uninterrupted API availability and consistent quality, which directly impacts the success of pharmaceutical products.

About Swapnroop Drugs and Pharmaceuticals

Company Overview

At Swapnroop Drugs and Pharmaceuticals, we take pride in being a trusted globalsupplier of pharmaceutical raw materials, delivering excellence, reliability, and regulatory compliance since 2013. Our strong industry presence and commitment to quality have made us a dependable partner for pharmaceutical companies worldwide.

Global Supply and Expertise

We specialize in supplying high-quality APIs, including Amlodipine Sulfate, to global markets. Our focus on quality assurance, timely delivery, and competitive pricing ensures customer satisfaction and long-term partnerships.

Conclusion

Amlodipine Sulfate (CAS 111470-99-6) is an important API in the treatment of cardiovascular diseases. Its effectiveness, stability, and growing demand make it a valuable component in pharmaceutical manufacturing. As the global market continues to expand, choosing high-quality API suppliers becomes essential for ensuring consistent product performance.

FAQs

1. What is Amlodipine Sulfate used for?

It is used to treat hypertension and angina by relaxing blood vessels and improving blood flow.

2. What is the CAS number of Amlodipine Sulfate?

The CAS number is 111470-99-6.

3. How does Amlodipine Sulfate work?

It blocks calcium channels in blood vessels, leading to relaxation and reduced blood pressure.

4. What are the storage conditions for Amlodipine Sulfate?

It should be stored in a cool, dry place away from light and moisture.

5. Why choose Swapnroop Drugs and Pharmaceuticals for APIs?

Swapnroop Drugs and Pharmaceuticals offers high-quality APIs with global supply capabilities, strict regulatory compliance, and trusted industry experience since 2013.

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