Product Description
Quinine Hydrochloride EP is a pharmaceutical-grade active pharmaceutical ingredient (API) primarily used for the treatment of malaria, muscle cramps, and fever reduction. It is a water-soluble salt derived from Cinchona bark, known for its antimalarial and muscle relaxant properties.
At Prism Industries Pvt. Ltd., we manufacture high-purity Quinine Hydrochloride EP following European Pharmacopoeia (EP) standards. Our Quinine Hydrochloride EP is produced under strict quality control measures, ensuring purity, potency, and compliance for pharmaceutical formulations.
Identification
- Chemical Name: Quinine Hydrochloride
- Molecular Formula: C20H24N2O2·HCl·2H2O
- Molecular Weight: 396.91 g/mol
- CAS Number: [Specific CAS Number]
- Synonyms: Quinine HCl, Hydrochloride of Quinine
- Appearance: White to slightly yellow crystalline powder
- Odor: Odorless or slightly bitter odor
- Solubility: Highly soluble in water, sparingly soluble in alcohol
- Function: Used as an antimalarial agent, muscle relaxant, and fever reducer
Quinine Hydrochloride EP is widely used in pharmaceutical formulations for oral and injectable medications, offering rapid absorption and high bioavailability.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that Quinine Hydrochloride EP meets global regulatory standards and provide the following regulatory documents:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with EP standards.
- Material Safety Data Sheet (MSDS): Provides safety, handling, and storage guidelines.
- Good Manufacturing Practices (GMP) Certificate: Ensures production under strict pharmaceutical-grade quality control.
- European Pharmacopoeia (EP) Compliance: Adheres to EP specifications for pharmaceutical use.
- TSE/BSE-Free Statement: Confirms that the product is free from animal-derived materials.
- Stability Data Report: Provides information on long-term stability under various conditions.
- Residual Solvents Report: Ensures compliance with ICH Q3C guidelines for safe solvent levels.
- Allergen-Free Statement: Certifies that the product is free from common allergens.
Our commitment to regulatory compliance ensures that Quinine Hydrochloride EP meets the highest quality and safety standards for pharmaceutical formulations.
Specifications of Quinine Hydrochloride EP
Our Quinine Hydrochloride EP is manufactured under strict quality control conditions, meeting the following pharmaceutical specifications:
Parameter | Specification |
Appearance | White to slightly yellow crystalline powder |
Odor | Odorless or faintly bitter odor |
Identification | Positive for Quinine Hydrochloride |
Melting Point | 175°C – 190°C |
Solubility | Freely soluble in water, sparingly soluble in alcohol |
pH (5% Solution in Water) | 4.5 – 6.5 |
Assay (Purity by HPLC) | 98.0% – 102.0% |
Loss on Drying | ≤ 2.0% |
Heavy Metals | ≤ 10 ppm |
Residual Solvents | Complies with ICH Q3C guidelines |
Microbial Limits | Complies with EP standards |
Our Quinine Hydrochloride EP meets strict pharmaceutical standards, ensuring its purity, consistency, and safety for medical and research applications.
Solubility of Quinine Hydrochloride EP
The solubility of Quinine Hydrochloride EP is a key factor in its pharmaceutical applications.
- Water: Freely soluble, making it ideal for oral and injectable formulations.
- Alcohol: Sparingly soluble.
- Acidic Solutions: Highly soluble, ensuring rapid absorption in the body.
- Organic Solvents: Partially soluble in some organic solvents like ether.
Due to its high water solubility, Quinine Hydrochloride EP is widely used in intravenous and oral dosage forms for rapid therapeutic action.
Assay of Quinine Hydrochloride EP
The assay of Quinine Hydrochloride EP is performed using High-Performance Liquid Chromatography (HPLC) to ensure purity and potency.
HPLC Assay Method for Quinine Hydrochloride EP
- Instrument: High-Performance Liquid Chromatography (HPLC)
- Mobile Phase: Acetonitrile: Water (60:40) with 0.1% phosphoric acid
- Column: C18 (250 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.0 mL/min
- Detection Wavelength: 254 nm
- Injection Volume: 10 µL
- Retention Time: 5.5 ± 0.3 minutes
- Assay Specification: 98.0% – 102.0%
Our Quinine Hydrochloride EP undergoes HPLC analysis to ensure it meets assay specifications, providing high purity and accurate dosage for pharmaceutical applications.
Chromatographic Purity by HPLC
The chromatographic purity of Quinine Hydrochloride EP is determined to identify and quantify impurities using HPLC methods.
HPLC Conditions for Chromatographic Purity Analysis
- Mobile Phase: Acetonitrile: Phosphate Buffer (70:30)
- Column: C18 (150 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.2 mL/min
- Detection Wavelength: 260 nm
- Retention Time: 5.0 ± 0.3 minutes
- Total Impurities Limit: ≤ 0.5%
Our Quinine Hydrochloride EP undergoes rigorous HPLC testing to ensure pharmaceutical-grade purity and efficacy.
Why Choose Prism Industries Pvt. Ltd. for Quinine Hydrochloride EP?
As a leading manufacturer of Quinine Hydrochloride EP, Prism Industries Pvt. Ltd. ensures:
Pharmaceutical-Grade Purity: Meets EP, GMP, and global pharmacopeial standards. High Solubility & Stability: Ensures fast absorption and effectiveness. Advanced Quality Control: Rigorous HPLC and microbiological testing. Global Regulatory Compliance: Ensures safety, purity, and compliance. Reliable Supply Chain: Capable of bulk production and worldwide distribution.
Quinine Hydrochloride EP is a highly effective antimalarial agent with excellent solubility, purity, and stability. At Prism Industries Pvt. Ltd., we ensure top-quality production, regulatory compliance, and superior quality control for Quinine Hydrochloride EP, making it ideal for pharmaceutical applications.
For high-quality Quinine Hydrochloride EP, contact us today for bulk supply and customized pharmaceutical solutions.
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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.