Quinine Hydrochloride: A Reliable API for Global Pharma Brands

Introduction: The Global Importance of Quinine Hydrochloride in Pharma

In the fast-changing world of pharmaceutical manufacturing, quinine hydrochloride remains a vital player. Sourced from the bark of the cinchona tree, this compound is a crucial therapeutic agent for treating malaria and febrile conditions. Renowned for its antimalarial, antipyretic, and analgesic properties, quinine hydrochloride continues to be sought after by global pharmaceutical brands for its effectiveness and reliability.

At Prism Industries Pvt. Ltd., we take pride in being a leading manufacturer of active pharmaceutical ingredients, providing top-notch quinine hydrochloride that meets international pharmacopoeial standards. With state-of-the-art infrastructure and extensive experience in pharma API manufacturing, we ensure consistent quality, prompt delivery, and comprehensive regulatory support.

This detailed guide delves into the production of quinine hydrochloride, its medical uses, and why Prism Industries is a trusted supplier on the global stage.

What is Quinine Hydrochloride?

Overview and Chemical Profile

Quinine hydrochloride is a salt form of quinine that dissolves easily in water and boasts high bioavailability. It’s commonly used in both intravenous and oral formulations to tackle severe malaria, especially when quick absorption is essential.

Molecular Formula: C20H24Cl2N2O2

Molecular Weight: 411.32 g/mol

Appearance: White crystalline powder

Solubility: Freely soluble in water, slightly soluble in alcohol

Pharmaceutical Applications of Quinine Hydrochloride

1. Malaria Treatment

The primary and most crucial use of quinine hydrochloride is in treating Plasmodium falciparum malaria. It works by inhibiting the growth and replication of the parasite in red blood cells.

2. Antipyretic and Analgesic Use

While less common today, quinine hydrochloride has historically been utilized for its ability to reduce fever and relieve pain.

3. Nocturnal Leg Cramps

In certain areas, small doses of quinine hydrochloride are prescribed to help alleviate muscle cramps and spasms.

At Prism Industries Pvt. Ltd., we take pride in our meticulous manufacturing process for Quinine Hydrochloride. Here’s a closer look at how we do it:

1. Extraction of Quinine Alkaloids

We kick things off by extracting alkaloids from premium cinchona bark, which we source from sustainable and traceable suppliers. This raw material goes through several steps:

- Acid-base extraction

- Treatment with organic solvents

- Precipitation and purification of the quinine base

2. Salt Formation: Hydrochloride Conversion

Next, we react the purified quinine base with hydrochloric acid, carefully controlling the temperature and pH to create quinine hydrochloride.

3. Crystallization and Drying

After forming the salt, we proceed with:

- Crystallizing it from an aqueous solution

- Filtering and washing to eliminate any impurities

- Drying it under vacuum to ensure optimal stability

4. Final QC and Batch Certification

Before we release each batch of quinine hydrochloride, it undergoes thorough quality control testing, which includes:

- HPLC to check for purity and potency

- Moisture content analysis using the Karl Fischer method

- Residual solvent analysis

- Testing for microbial presence and heavy metals

Why Prism Industries Pvt. Ltd. is a Trusted Supplier

1. WHO-GMP Certified Facilities

As a leading name in pharma API manufacturing, we proudly operate under WHO-GMP standards. This means our quinine hydrochloride is crafted to meet the highest safety and efficacy benchmarks.

2. Regulatory Documentation and Support

We offer a comprehensive suite of documentation, including:

- Certificate of Analysis (COA)

- Material Safety Data Sheet (MSDS)

- Drug Master File (DMF) support

- Stability data

- TSE/BSE certificates

Our thorough documentation ensures a seamless product registration process with regulatory bodies like the USFDA, EMA, TGA, and more.

3. Custom API Solutions

We excel in providing tailored API manufacturing solutions to meet your unique formulation needs, such as:

- Customized particle size

- Solubility enhancements

- Special packaging

- Stability profiles

Advantages of Quinine Hydrochloride API

1. Quick Action

Thanks to its excellent solubility in water, quinine hydrochloride works swiftly, making it a go-to choice for emergency and IV treatments for malaria.

2. Established Safety Record

With decades of use around the world, quinine hydrochloride boasts a solid track record for safety and effectiveness in clinical environments.

3. Versatile Dosage Options

It’s suitable for various forms, including:

- Injectable solutions

- Capsules and tablets

- Oral suspensions

This versatility makes it a valuable option for pharmaceutical manufacturers.

Global Demand and Supply Dynamics

The demand for reliable quinine hydrochloride is on the rise in countries where malaria is prevalent, including:

- Africa

- Southeast Asia

- South America

- India

As a trusted bulk API manufacturer, Prism Industries Pvt. Ltd. is well-equipped to meet these needs through:

- Streamlined logistics

- Regulatory compliance

- Consistent batch quality

Packaging and Logistics at Prism Industries Pvt. Ltd.

We provide quinine hydrochloride in:

- HDPE drums featuring double-layer inner liners

- Vacuum-sealed packaging

- Tamper-proof labels and batch codes

Every shipment includes:

- International shipping documents

- Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS)

- Support for product traceability

Sustainability in Quinine Hydrochloride Production

As a forward-thinking manufacturer of bulk drugs, we proudly embrace:

- Green chemistry principles

- Solvent recovery systems

- Eco-friendly waste treatment

We prioritize ethical sourcing and ensure fair-trade practices when procuring cinchona bark.

Our Role as Active Pharmaceutical Ingredient Manufacturers

With a wealth of experience in producing pharmaceutical APIs, we offer much more than just manufacturing. Our services include:

- API consultation

- Regulatory compliance assistance

- Formulation development support

Our clients rely on us not only for quinine hydrochloride but also for a diverse array of active pharmaceutical ingredients across various therapeutic categories.

Certifications and Industry Recognition

We are proud to be certified and recognized by:

- WHO-GMP

- ISO 9001:2015 (Quality Management)

- ISO 14001:2015 (Environmental Management)

- ISO 45001:2018 (Occupational Health and Safety)

These certifications highlight our unwavering commitment to quality, safety, and sustainability.

FAQs about Quinine Hydrochloride API

1. What’s the typical assay for quinine hydrochloride API?

Most pharmaceutical-grade quinine hydrochloride typically has an assay ranging from 98.5% to 101.0%, in line with pharmacopeial standards.

2. What are the recommended storage conditions?

It’s best to keep it in a cool, dry spot below 25°C, stored in tightly sealed containers, and away from light and moisture.

3. Does Prism offer support for regulatory filings?

Absolutely! We provide thorough assistance for DMFs, CTD dossiers, and other regulatory filings on a global scale.

Conclusion: Partner with Prism Industries for Quinine Hydrochloride Excellence

As the need for reliable antimalarial treatments continues to rise, sourcing high-quality quinine hydrochloride from trusted partners becomes increasingly vital. At Prism Industries Pvt. Ltd., we take pride in being one of the most reliable active pharmaceutical ingredient manufacturers in the industry, offering comprehensive support from API manufacturing to global distribution.

With a strong emphasis on quality, innovation, and compliance, our quinine hydrochloride enables pharmaceutical companies worldwide to develop effective, life-saving medications. For unmatched purity, consistent performance, and global support, choose Prism Industries Pvt. Ltd. — your trusted source for quinine hydrochloride.