Product Description
Quinidine Base is a potent active pharmaceutical ingredient (API) widely used in the treatment of cardiac arrhythmias. This natural alkaloid, derived from the bark of the cinchona tree, plays a crucial role in stabilizing heart rhythm and preventing irregular heartbeats. It is also studied for its potential antimalarial properties. Prism Industries Pvt. Ltd. is a leading manufacturer and supplier of Quinidine Base, ensuring high purity and pharmaceutical-grade quality.
Identification
Chemical Name: Quinidine Base
Molecular Formula: C20H24N2O2
Molecular Weight: 324.42 g/mol
CAS Number: 56-54-2
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 168-172°C
Solubility: Soluble in ethanol, slightly soluble in water
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure compliance with international pharmaceutical standards. Our Quinidine Base meets the regulatory requirements of major health authorities, including:
USP (United States Pharmacopeia)
EP (European Pharmacopoeia)
BP (British Pharmacopoeia)
GMP (Good Manufacturing Practices) Certified
ISO 9001:2015 Certified Facility
We provide comprehensive regulatory support, including Certificates of Analysis (COA), Material Safety Data Sheets (MSDS), and GMP Compliance Statements.
Specifications
| Test Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Positive for Quinidine Base |
| Melting Point | 168-172°C |
| Assay (HPLC) | 98.0% – 102.0% |
| Chromatographic Purity | Complies with EP/USP standards |
| Loss on Drying | ≤ 0.5% |
| Heavy Metals | ≤ 10 ppm |
| Specific Rotation | -160° to -175° |
Solubility
Quinidine Base exhibits varying solubility properties:
Freely soluble in ethanol, chloroform, and acetone.
Slightly soluble in water.
Practically insoluble in ether.
This solubility profile makes it a valuable active pharmaceutical ingredient for different formulation methods, including tablets and injectables.
Assay
Quinidine Base is tested using High-Performance Liquid Chromatography (HPLC) to ensure potency and purity. The assay specification is set between 98.0% and 102.0%, confirming pharmaceutical-grade quality.
Chromatographic Purity by HPLC
To maintain high-quality standards, Prism Industries Pvt. Ltd. performs advanced HPLC testing to detect impurities. Our stringent quality control measures ensure:
No individual impurity exceeds the pharmacopoeial limit.
Total impurities remain within acceptable regulatory limits.
Batch-to-batch consistency and stability.
Why Choose Prism Industries Pvt. Ltd. for Quinidine Base?
1. Pharmaceutical-Grade Purity
We adhere to strict GMP-certified manufacturing processes to produce Quinidine Base with the highest purity and stability.
2. Reliable API Manufacturer
As a leading API pharmaceutical company, we supply active pharma ingredients to pharmaceutical companies globally, ensuring consistent quality and regulatory compliance.
3. Advanced Quality Control
Our state-of-the-art laboratory performs rigorous HPLC and spectroscopic analysis to guarantee chromatographic purity and assay precision.
4. Regulatory Compliance & Documentation
We provide all necessary documentation, including COA, MSDS, and stability studies, making regulatory approvals seamless for our clients.
Prism Industries Pvt. Ltd. is committed to providing high-quality active pharma ingredients like Quinidine Base for global pharmaceutical applications. Our expertise in the API manufacturing industry ensures that our customers receive superior-quality active pharmaceutical ingredients with unmatched consistency.
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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.