Quinine Sulphate USP: A Key Pharma API in Bulk Drug Manufacturing

 Quinine Sulphate USP is a widely used pharmaceutical ingredient known for its effectiveness in treating malaria and other medical conditions. As a leading bulk drugs manufacturer, Prism Industries Pvt. Ltd. is committed to producing high-quality APIs pharmaceutical products that meet global regulatory standards.

In the pharma API manufacturing industry, Quinine Sulphate USP plays a crucial role as a therapeutic agent, and its demand continues to rise across pharmaceutical markets worldwide. As a trusted supplier, Prism Industries Pvt. Ltd. ensures that our pharma ingredients meet the highest purity, safety, and efficacy standards.

This article explores the significance of Quinine Sulphate USP, its role in the pharma industry, its manufacturing process, and why Prism Industries Pvt. Ltd. is the best choice for bulk drug manufacturing.






1. What is Quinine Sulphate USP?

Quinine Sulphate USP is an Active Pharmaceutical Ingredient (API) derived from the bark of the Cinchona tree. It is primarily used in the treatment of malaria, as well as in the management of leg cramps and other muscle-related disorders.

1.1 Chemical and Physical Properties

  • Chemical Formula: C₂₀H₂₄N₂O₂•H₂SO₄

  • Molecular Weight: 782.96 g/mol

  • Appearance: White crystalline powder

  • Solubility: Slightly soluble in water, freely soluble in alcohol

  • Odor & Taste: Characteristic bitter taste

As a high-purity pharma API, Quinine Sulphate USP is essential for pharmaceutical formulations, particularly for antimalarial drugs.


2. Applications of Quinine Sulphate USP in Pharma API Manufacturing

2.1 Treatment of Malaria

  • Quinine Sulphate USP has been used for centuries as a reliable antimalarial drug.

  • It works by interfering with the growth of Plasmodium parasites, preventing the spread of malaria in the body.

  • Despite the availability of newer antimalarial drugs, Quinine Sulphate USP remains a crucial component in severe malaria treatment.

2.2 Management of Muscle Cramps

  • Due to its muscle relaxant properties, Quinine Sulphate USP is used to treat nocturnal leg cramps and muscle spasms.

  • It helps reduce the frequency and severity of cramps, especially in elderly patients.

2.3 Fever and Pain Relief

  • Traditionally, Quinine Sulphate USP has been used for its antipyretic (fever-reducing) and analgesic (pain-relieving) properties.

  • It remains an important pharma ingredient in various pain management therapies.

2.4 Potential Uses in Other Medical Conditions

  • Research suggests that Quinine Sulphate USP may be beneficial in treating autoimmune disorders, arthritis, and certain neurological conditions.

  • Ongoing studies aim to explore its broader applications in the pharma industry.


3. The Role of Bulk Drugs Manufacturers in Pharma API Manufacturing

3.1 What is Bulk Drug Manufacturing?

  • Bulk drug manufacturing refers to the large-scale production of active pharmaceutical ingredients (APIs), which are later formulated into final pharmaceutical products.

  • As a leading bulk drugs manufacturer, Prism Industries Pvt. Ltd. ensures the consistent quality and supply of Quinine Sulphate USP for pharmaceutical companies worldwide.

3.2 Key Aspects of Pharma API Manufacturing

  • High-Purity Production – Ensuring that APIs pharmaceutical products meet regulatory standards.

  • Quality Control & Testing – Conducting rigorous testing using HPLC, GC, and titration methods.

  • Regulatory Compliance – Adhering to USP, EP, and GMP standards for global pharmaceutical applications.

  • Sustainable Sourcing – Using eco-friendly and ethical raw material procurement methods.

3.3 Importance of Pharma Ingredients in API Production

  • Pharma ingredients like Quinine Sulphate USP serve as essential components in drug formulations.

  • The efficiency of a pharmaceutical product depends on the purity, consistency, and bioavailability of its active pharma ingredients.

At Prism Industries Pvt. Ltd., we focus on high-quality pharma API manufacturing to provide trusted API solutions for global pharmaceutical markets.


4. Regulatory Standards and Quality Assurance for Quinine Sulphate USP

4.1 Compliance with International Standards

To ensure safety and efficacy, Quinine Sulphate USP must meet the following regulatory requirements:
 ✔ United States Pharmacopeia (USP) Compliance
 ✔ Good Manufacturing Practices (GMP) Certification
 ✔ ISO 9001:2015 Certified Production
 ✔ FDA & REACH Regulatory Approvals
 ✔ COA, MSDS, and DMF Documentation Available

4.2 Quality Testing Methods

At Prism Industries Pvt. Ltd., we use advanced analytical techniques to ensure the purity and stability of Quinine Sulphate USP:

  • High-Performance Liquid Chromatography (HPLC) – Determines API purity.

  • Gas Chromatography (GC) – Identifies residual solvents.

  • Titration Analysis – Confirms active compound concentration.

  • Heavy Metal Testing – Ensures compliance with safety standards.

Our state-of-the-art manufacturing facilities guarantee high-quality bulk drugs production, ensuring consistent APIs pharmaceutical supply to our clients.


5. Why Choose Prism Industries Pvt. Ltd. for Quinine Sulphate USP?

5.1 High-Quality Manufacturing Process

  • We utilize cutting-edge pharma API manufacturing technologies to produce high-purity Quinine Sulphate USP.

  • Our bulk drugs manufacturing process follows strict regulatory standards to ensure superior product quality.

5.2 Reliable Supply Chain & Bulk Drug Distribution

  • As a trusted bulk drugs manufacturer, we ensure timely delivery of Quinine Sulphate USP worldwide.

  • Our pharma API manufacturing facility maintains large-scale production capabilities to meet growing market demands.

5.3 Competitive Pricing & Cost-Effective Solutions

  • We offer cost-efficient pharma ingredients without compromising on quality or safety.

  • Our bulk supply chain allows us to provide affordable API pharmaceutical solutions for pharmaceutical companies.

5.4 Strong Regulatory & Technical Support

  • We provide complete regulatory documentation, technical support, and customized API solutions.

  • Our experienced R&D team ensures that our pharma ingredients meet global market requirements.


Conclusion: The Future of Quinine Sulphate USP in Pharma API Manufacturing

Quinine Sulphate USP continues to be an essential API pharmaceutical product in the pharma industry, especially in the treatment of malaria, muscle disorders, and pain management. As the demand for high-purity pharma ingredients grows, bulk drugs manufacturers must ensure consistent quality and regulatory compliance.

At Prism Industries Pvt. Ltd., we are committed to producing top-quality Quinine Sulphate USP through advanced pharma API manufacturing techniques. Our dedication to excellence, innovation, and global regulatory standards makes us the preferred choice for pharmaceutical companies worldwide.

📩 Contact Us Today for Bulk Orders & Custom API Solutions! 🚀
Location: Vadodara, Gujarat, India

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