Product Description
Quinine Bisulphate is a natural alkaloid derived from the Cinchona tree, widely known for its antimalarial and medicinal properties. It is a crucial pharmaceutical ingredient used in the treatment of malaria, muscle cramps, and cardiac arrhythmias. The bisulphate form enhances the solubility and bioavailability of quinine alkaloids, making it a preferred choice for pharmaceutical formulations. With a history of proven efficacy, Quinine Bisulphate remains an essential component in modern medicine.
Identification
- Chemical Name: Quinine Bisulphate
- Molecular Formula: (C20H24N2O2)2·H2SO4·2H2O
- Molecular Weight: 782.96 g/mol
- CAS Number: 549-56-4
- Appearance: White to pale yellow crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water and alcohol
Regulatory Documents & Compliance
As a globally recognized API pharmaceutical company, Prism Industries Pvt. Ltd. ensures that Quinine Bisulphate complies with all major pharmaceutical regulatory standards, including:
- United States Pharmacopoeia (USP)
- European Pharmacopoeia (EP)
- Good Manufacturing Practices (GMP)
- World Health Organization (WHO) GMP Guidelines
- ISO 9001 & 14001 Certified
We provide comprehensive regulatory documents such as Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and Batch Manufacturing Records (BMR) to ensure transparency and quality assurance.
Specifications
Test Parameter | Specification |
Appearance | White to pale yellow crystalline powder |
Identification | Confirms presence of quinine alkaloid |
Assay (by HPLC) | ≥ 98.0% |
Residual Solvents | Meets ICH Q3C Guidelines |
Loss on Drying | ≤ 1.0% |
Heavy Metals | ≤ 10 ppm |
Microbial Limits | Meets USP/EP guidelines |
Solubility
- Freely soluble in water, ethanol, and methanol.
- Slightly soluble in chloroform and ether.
- High solubility enhances bioavailability in pharmaceutical formulations.
Assay (Purity Testing)
Our Quinine Bisulphate undergoes strict purity testing using High-Performance Liquid Chromatography (HPLC), ensuring an assay value of ≥ 98.0%. The testing confirms the compound’s integrity and compliance with industry standards.
Chromatographic Purity by HPLC
The chromatographic purity of Quinine Bisulphate is determined through HPLC analysis, ensuring that all related impurities are controlled within permissible limits.
Impurity | Limit |
Any individual impurity | ≤ 0.2% |
Total impurities | ≤ 1.0% |
Why Choose Prism Industries Pvt. Ltd. for Quinine Bisulphate?
1. High Purity & Quality Assurance
Our Quinine Bisulphate is produced under strict GMP guidelines, ensuring high purity (≥ 98.0%) and adherence to global pharmacopoeial standards.
2. Advanced Manufacturing Facility
With cutting-edge technology, our facility ensures efficient production, strict quality control, and batch-to-batch uniformity for pharmaceutical formulations.
3. Stringent Regulatory Compliance
We comply with all major pharmaceutical regulatory bodies, including USP, EP, and WHO-GMP standards, ensuring reliability and safety in pharmaceutical applications.
4. Custom API Solutions
We offer tailored API solutions to meet the specific needs of pharmaceutical companies. Our team provides flexible packaging options and customized formulations.
5. Reliable Supply Chain & Global Distribution
With a robust global presence, we ensure on-time delivery and seamless logistics management, making us a trusted partner for pharmaceutical manufacturers worldwide.
As a leading API pharmaceutical company, Prism Industries Pvt. Ltd. specializes in the production of Quinine Bisulphate, adhering to the highest pharmaceutical standards. Our commitment to quality, innovation, and compliance ensures that pharmaceutical companies receive the best raw materials for their formulations.
Contact us today to learn more about our Quinine Bisulphate production and API manufacturing services.
New headquarters, new possibilities
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.