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 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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