Product Description
Quinine Sulphate is a naturally occurring alkaloid derived from the bark of the cinchona tree. It has been widely used for centuries as a potent antimalarial agent. In modern medicine, Quinine Sulphate continues to serve as an essential therapeutic component, particularly for treating malaria caused by Plasmodium falciparum, especially in regions with resistance to other antimalarial drugs. This API is available in both oral and injectable formulations, typically in salt form, to ensure stability and solubility.
In addition to its antimalarial use, Quinine Sulphate is also recognized for its muscle relaxant properties and is sometimes used for treating nocturnal leg cramps and related muscle spasms. At Prism Industries Pvt. Ltd., we produce high-quality Quinine Sulphate that complies with multiple pharmacopeial standards, ensuring global usability.
Identification
Chemical Name: Quinine Sulphate
Synonyms: Quinine hemisulfate, Quinine sulfate dihydrate
Molecular Formula: C40H54N4O10S
Molecular Weight: Approximately 782.96 g/mol (anhydrous basis)
CAS Number: 804-63-7
Appearance: White or almost white, crystalline powder
Odor: Odorless or slight characteristic odor
Taste: Bitter
Origin: Plant-based, extracted from cinchona bark
Regulatory Documents & Compliance
Prism Industries Pvt. Ltd. ensures full regulatory compliance for Quinine Sulphate by maintaining a complete dossier and certifications required for export and registration in regulated and semi-regulated markets.
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
WHO-GMP Certification
ISO 9001:2015 Certification
Drug Master File (DMF) – available on request
REACH Compliance (for applicable countries)
Product Dossier / CTD format – Available
Our regulatory team provides end-to-end support in documentation, product registration, and audit compliance for our global partners.
Specifications
Assay (on anhydrous basis): 98.0% to 102.0%
Identification (IR, UV): Complies with pharmacopeial requirements
Melting Point: 205 – 225°C
Loss on Drying: Not more than 9.0%
Residue on Ignition: Not more than 0.1%
Heavy Metals: Not more than 20 ppm
Chloride and Sulphate Test: Passes test
Optical Rotation: −238° to −252°
Microbial Limits: Complies with pharmacopeial standards
Storage: Store in tightly sealed containers away from light and moisture
Each batch of Quinine Sulphate undergoes strict quality control testing and validation in our ISO-certified laboratories.
Solubility
Quinine Sulphate exhibits moderate solubility in water, which is why it is often formulated as a salt. It is slightly soluble in alcohol and practically insoluble in ether. To enhance bioavailability and ease of formulation, Quinine Sulphate is typically used in finely milled crystalline form.
Water Solubility: 1 g in approximately 1,000 mL (enhanced by heat)
Solubility in Diluted Acids: Freely soluble
Solubility in Ethanol: Slightly soluble
Our technical team supports clients with formulation recommendations based on solubility profiles.
Assay
Each lot of Quinine Sulphate produced by Prism Industries Pvt. Ltd. undergoes rigorous assay procedures to ensure potency and uniformity. The assay is conducted using validated methods such as HPLC or UV-Vis spectrophotometry in compliance with pharmacopeial standards like IP, BP, and USP.
Typical Assay Range: 99.0% – 101.0%
Test Method: UV Spectroscopy / HPLC
Validated Against: Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP)
We provide assay data and method validation reports as part of the regulatory dossier.
Why Choose Prism Industries Pvt. Ltd. for Quinine Sulphate
At Prism Industries Pvt. Ltd., we take pride in offering superior quality Quinine Sulphate that meets global regulatory and technical benchmarks. Here’s why leading pharmaceutical companies worldwide choose us:
1. High-Quality Sourcing
We utilize sustainably harvested cinchona bark for the extraction of Quinine Sulphate, ensuring consistent quality and traceability.
2. State-of-the-Art Manufacturing
Our WHO-GMP certified facilities are equipped with modern machinery and automated process controls, ensuring safe and efficient production of API Bulk Drugs.
3. Global Compliance
With a strong focus on regulatory adherence, we supply Quinine Sulphate to over 30 countries. Our products are accepted in both regulated and semi-regulated markets.
4. Robust R&D and Custom Solutions
Our in-house R&D team develops custom specifications and supports clients with technical documentation, samples, and formulation optimization.
5. Comprehensive Documentation
We offer a complete regulatory package including COA, MSDS, DMF, CTD dossiers, and method validations for a seamless product registration process.
6. Reliable Supply Chain
With a streamlined supply chain and logistics infrastructure, we ensure on-time delivery and responsive client support, making us a dependable Quinine Sulphate supplier.
7. Customer-Centric Approach
Our team works closely with clients to understand project needs and deliver customized solutions backed by strong technical support.
Quinine Sulphate remains a critical pharmaceutical ingredient, especially for antimalarial treatments in regions where resistance is prevalent. Prism Industries Pvt. Ltd. is committed to supplying high-quality, pharmacopeia-compliant Quinine Sulphate with the documentation and technical support our partners need to succeed.
Whether you’re looking to source for commercial production, R&D, or regulatory submission, trust Prism as your reliable API partner.
Contact us today for samples, quotations, or regulatory support for Quinine Sulphate.
FAQs:
Quinine Sulphate is a pharmaceutical active ingredient derived from the bark of the Cinchona tree. It belongs to the quinoline alkaloid family and is widely recognized for its antimalarial properties.
Prism Industries Pvt. Ltd. is a Quinine Sulphate manufacturer in India, supplying pharmaceutical-grade Quinine Sulphate for pharmaceutical manufacturing, commercial requirements, R&D, and regulatory applications.
Quinine Sulphate is primarily used as an active pharmaceutical ingredient in antimalarial medicines. Pharmaceutical manufacturers use the API in suitable formulations according to applicable regulatory requirements and approved product specifications.
Quinine Sulphate is derived from Cinchona bark, a natural plant source containing quinoline alkaloids. Prism Industries uses Cinchona-derived raw material for its Quinine Sulphate production.
Prism Industries manufactures Quinine Sulphate to meet different pharmacopeial requirements, including USP, BP and IP standards, depending on customer and market requirements.
The CAS number listed for Quinine Sulphate on Prism Industries’ product page is 804-63-7.
Quinine Sulphate typically appears as a white or almost white crystalline powder with a characteristically bitter taste
Prism Industries lists a typical Quinine Sulphate assay range of approximately 99.0%–101.0%, with testing performed using validated analytical methods such as HPLC or UV spectroscopy. Final specifications should be confirmed through the batch Certificate of Analysis.
Prism Industries can provide supporting documentation such as a Certificate of Analysis (COA), MSDS, DMF support, CTD/product dossier and method validation documentation, subject to applicable requirements and availability.
Yes. A Certificate of Analysis (COA) is available to provide batch-specific information regarding quality, assay and applicable specifications.
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Related Products
Our minimum order quantities vary depending on the product:
- Active Pharmaceutical Ingredients (APIs): 1 kg
- Excipients: 5 kg
- Finished Dosage Forms: 1,000 units
- Custom Orders: Determined on a case-by-case basis
We accept the following payment methods:
- Bank Transfers: EUR, USD, GBP
- Credit/Debit Cards: Visa, MasterCard
- PayPal: For international transactions
API Pharmaceutical Manufacturing Company is a dedicated manufacturer of high-quality pharmaceutical ingredients and finished products. We control the entire production process to ensure compliance with the highest standards of quality and safety.
We primarily serve business clients in the pharmaceutical, biotech, and healthcare industries. For individual customers, we recommend reaching out to our authorized distributors.