Product Description
Cinchonine is a natural alkaloid extracted from the bark of the Cinchona tree, known for its pharmaceutical and medicinal applications. It is widely used in antimalarial, cardiovascular, and anti-inflammatory drug formulations. As a crucial Active Pharmaceutical Ingredient (API), Cinchonine is extensively researched and utilized for its therapeutic benefits in the pharmaceutical industry. With high purity and excellent solubility, it plays an essential role in modern medicine.
Identification
- Chemical Name: Cinchonine
- Molecular Formula: C19H22N2O
- Molecular Weight: 294.39 g/mol
- CAS Number: 118-10-5
- Appearance: White to pale yellow crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in alcohol, slightly soluble in water
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that Cinchonine meets international pharmaceutical standards and complies with global regulatory requirements. Our products adhere to the following:
- 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, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and Batch Manufacturing Records (BMR), ensuring full transparency and compliance.
Specifications
Test Parameter | Specification |
Appearance | White to pale yellow crystalline powder |
Identification | Confirms presence of cinchonine 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 ethanol, methanol, and chloroform.
- Slightly soluble in water.
- Solubility adjustments improve formulation efficiency in pharmaceuticals.
Assay (Purity Testing)
Our Cinchonine undergoes rigorous purity testing using High-Performance Liquid Chromatography (HPLC) to ensure an assay value of ≥ 98.0%. This testing guarantees product integrity and pharmaceutical-grade quality.
Chromatographic Purity by HPLC
The chromatographic purity of Cinchonine 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 Cinchonine?
1. High Purity & Quality Assurance
Our Cinchonine is manufactured under strict GMP guidelines, ensuring high purity (≥ 98.0%) and compliance with 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 adhere to all major global pharmaceutical regulatory bodies, including USP, EP, and WHO-GMP standards, ensuring product reliability and safety.
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 strong 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 Cinchonine, 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 Cinchonine production and API manufacturing services.
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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.