A Comprehensive Guide to Quinine Sulphate Production
As a leading manufacturer of Quinine Sulphate, Prism Industries Pvt. Ltd. is dedicated to providing high-quality active pharmaceutical ingredients (APIs) to our global pharmaceutical partners. Quinine sulphate, an essential alkaloid derived from the bark of the cinchona tree, has been a cornerstone in the fight against malaria for many years. In this guide, we’ll delve into the intricate production process, the significance of quinine sulphate in the industry, the compliance standards we adhere to, and the innovative strides Prism Industries is making in its manufacturing.
Understanding Quinine Sulphate: A Historical and Medical Perspective
Quinine sulphate is a naturally occurring compound celebrated for its effectiveness in treating malaria. While its primary use has been in combating this disease, it also serves to alleviate muscle cramps and nocturnal leg cramps. Sourced from the bark of the cinchona tree, this compound is recognized as one of the essential active pharmaceutical ingredients that address global health challenges.
At Prism Industries Pvt. Ltd., we take pride in our meticulous Step-by-Step Production Process.
Raw Material Procurement
We source high-quality cinchona bark from reliable global suppliers, ensuring that our materials are both sustainable and traceable to meet environmental standards.
Extraction
Our alkaloid extraction process employs a controlled solvent method to effectively isolate the base alkaloid. We keep a close eye on the extraction to guarantee optimal purity levels.
Purification
We utilize a multi-step purification process that includes recrystallization and pH adjustments, which helps us eliminate any residual plant materials and other alkaloids.
Synthesis to Sulphate Salt
The purified quinine base is then subjected to sulfonation, resulting in quinine sulphate. We conduct quality control checks at every stage of the batch conversion to ensure consistency.
Drying and Milling
The resulting powder is dried under vacuum conditions and milled to achieve a uniform particle size, which is carefully adjusted for optimal dissolution and bioavailability.
Quality Assurance and Lab Testing
We perform extensive in-house testing using advanced techniques like HPLC and FTIR, ensuring that our products comply with IP, BP, USP, and EP pharmacopoeia standards.
Packaging and Storage
Our active pharmaceutical ingredients (APIs) are packed in HDPE drums with double-layer liners to prevent moisture exposure. We store them in a humidity-controlled environment to maintain their stability.
Why Choose Prism Industries as Your Quinine Sulphate Manufacturer
Regulatory Compliance: We adhere to WHO-GMP, ISO, and FDA regulations.
Global Reach: Our products are supplied to over 40 countries around the globe.
Custom API Manufacturing: We offer tailored particle sizes and specifications to meet your needs.
Environmental Responsibility: We practice zero-liquid discharge and embrace green chemistry.
Expertise in APIs: With decades of experience, we excel in producing high-quality active pharmaceutical ingredients.
Antimalarial Formulations: This is the go-to treatment for Plasmodium falciparum.
Cramp Relief: In low doses and with a prescription, it’s used to help with leg cramps.
Combination Drugs: It’s often combined with antibiotics or antipyretics for better effectiveness.
Veterinary Uses: Some formulations are also beneficial in animal health.
Prism Industries’ Commitment to Quality
Every batch of quinine sulphate is put through thorough documentation and testing before it’s sent out. Prism Industries adheres to strict ICH Q7 and ICH Q3D standards, which means they focus on controlling elemental impurities, stability profiling, and ensuring batch traceability.
Research & Development Focus
Prism Industries is all about innovation, investing in:
Better purification techniques
Eco-friendly extraction methods
New salt forms and derivatives that improve solubility
Supply Chain and Logistics
Their global warehousing partners guarantee timely deliveries.
They also have cold chain logistics in place for sensitive pharmaceutical APIs.
Plus, they provide custom documentation and clearance support for international clients.
At Prism Industries Pvt. Ltd., we take pride in being a leading manufacturer of quinine sulphate, known for our commitment to excellence. With a strong foundation built on innovation, quality assurance, and adherence to regulations, we are your reliable global partner for high-purity active pharmaceutical ingredients.
Choose Prism Industries Pvt. Ltd. as your go-to source for top-notch quinine sulphate APIs.
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