Product Description
Quinine Sulphate IP is a pharmaceutical-grade active pharmaceutical ingredient (API) widely used for the treatment of malaria, nocturnal leg cramps, and other medical conditions. It is derived from the Cinchona bark, making it a natural alkaloid with powerful antimalarial properties.
At Prism Industries Pvt. Ltd., we specialize in the production of high-purity Quinine Sulphate IP, ensuring compliance with Indian Pharmacopeia (IP) standards. Our Quinine Sulphate IP undergoes rigorous quality control, making it suitable for pharmaceutical formulations, research, and global healthcare applications.
Identification
- Chemical Name: Quinine Sulphate
- Molecular Formula: (C20H24N2O2)2·H2SO4·2H2O
- Molecular Weight: 782.96 g/mol
- CAS Number: [Specific CAS Number]
- Synonyms: Quinine Sulfate, Sulfate of Quinine
- Appearance: White or slightly yellow crystalline powder
- Odor: Odorless or slightly bitter odor
- Solubility: Freely soluble in water, sparingly soluble in alcohol
- Function: Used as an antimalarial agent, muscle relaxant, and anti-inflammatory
Quinine Sulphate IP is known for its high efficacy in treating malaria, especially against Plasmodium falciparum infections. It is also used in certain pain-relieving formulations due to its muscle relaxant properties.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that our Quinine Sulphate IP meets global regulatory standards. We provide the following regulatory documents to support compliance and safety assurance:
- Certificate of Analysis (COA): Confirms purity, potency, and quality of the product.
- Material Safety Data Sheet (MSDS): Contains safety precautions, handling guidelines, and storage requirements.
- Good Manufacturing Practices (GMP) Certificate: Guarantees quality-controlled manufacturing.
- Indian Pharmacopeia (IP) Compliance: Meets IP standards for pharmaceutical applications.
- TSE/BSE-Free Statement: Certifies the absence of animal-derived components.
- Stability Data Report: Provides details on long-term product stability under various conditions.
- Residual Solvents Report: Ensures compliance with ICH Q3C guidelines.
- Allergen-Free Statement: Confirms the absence of common allergens.
Our commitment to regulatory compliance ensures that Quinine Sulphate IP meets strict quality and safety standards, making it safe and reliable for pharmaceutical formulations.
Specifications of Quinine Sulphate IP
Our Quinine Sulphate IP is manufactured under strict quality control conditions, meeting the following specifications:
Parameter | Specification |
Appearance | White to slightly yellow crystalline powder |
Odor | Odorless or faintly bitter odor |
Identification | Positive for Quinine Sulphate |
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 pharmacopeial standards |
The high purity and quality of our Quinine Sulphate IP make it ideal for use in pharmaceutical formulations and medical treatments.
Solubility of Quinine Sulphate IP
The solubility properties of Quinine Sulphate IP play a crucial role in its pharmaceutical applications.
- Water: Freely soluble (making it suitable for oral and injectable formulations).
- Alcohol: Sparingly soluble.
- Acidic Solutions: Highly soluble, aiding in rapid absorption in the body.
- Organic Solvents: Partial solubility in some solvents like ether.
Due to its excellent solubility in water, Quinine Sulphate IP is widely used in liquid formulations for malaria treatment and muscle relaxation therapies.
Assay of Quinine Sulphate IP
The assay for Quinine Sulphate IP is determined using High-Performance Liquid Chromatography (HPLC) to analyze purity and content accuracy.
HPLC Assay Method for Quinine Sulphate IP
- 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 Sulphate IP undergoes HPLC analysis to ensure it meets assay specifications, providing high purity and accurate dosage in pharmaceutical applications.
Chromatographic Purity by HPLC
The chromatographic purity of Quinine Sulphate IP 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 Sulphate IP undergoes strict HPLC testing to ensure its chromatographic purity, making it a safe and effective pharmaceutical ingredient.
Why Choose Prism Industries Pvt. Ltd. for Quinine Sulphate IP?
As a leading manufacturer of Quinine Sulphate IP, Prism Industries Pvt. Ltd. ensures:
Pharmaceutical-Grade Purity: Meets IP, GMP, and pharmacopeial standards. High Solubility & Stability: Ensures rapid 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 Sulphate IP 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 Sulphate IP, making it ideal for pharmaceutical applications.
For high-quality Quinine Sulphate IP, contact us today for bulk supply and customized pharmaceutical solutions.
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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.