Product Description
Quinine Sulphate BP is a pharmaceutical-grade active pharmaceutical ingredient (API) widely used for the treatment of malaria, nocturnal leg cramps, and certain muscle disorders. Derived from the Cinchona tree bark, it is a natural alkaloid known for its antimalarial, antipyretic, and muscle relaxant properties.
At Prism Industries Pvt. Ltd., we specialize in the manufacturing of high-purity Quinine Sulphate BP, ensuring strict compliance with British Pharmacopoeia (BP) standards. Our Quinine Sulphate BP undergoes rigorous testing to meet international quality, safety, and regulatory standards, making it ideal for pharmaceutical formulations.
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, Sulphate of Quinine
- Appearance: White to 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 fever reducer
Quinine Sulphate BP is highly effective in the treatment of malaria, particularly against Plasmodium falciparum infections. It is also used in pharmaceutical muscle relaxant formulations due to its neuroprotective and analgesic properties.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that our Quinine Sulphate BP meets global regulatory requirements. We provide the following regulatory documents to support compliance and quality assurance:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with BP standards.
- Material Safety Data Sheet (MSDS): Provides safety measures, handling instructions, and storage guidelines.
- Good Manufacturing Practices (GMP) Certificate: Ensures that production meets pharmaceutical manufacturing standards.
- British Pharmacopoeia (BP) Compliance: Adheres to BP specifications for pharmaceutical-grade Quinine Sulphate.
- TSE/BSE-Free Statement: Certifies the absence of animal-derived components.
- Stability Data Report: Includes information on long-term stability and storage 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 Sulphate BP meets strict pharmaceutical industry standards, making it a safe and reliable API for pharmaceutical formulations.
Specifications of Quinine Sulphate BP
Our Quinine Sulphate BP 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 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 BP standards |
The high purity and compliance of our Quinine Sulphate BP make it suitable for use in pharmaceutical formulations and therapeutic applications.
Solubility of Quinine Sulphate BP
The solubility properties of Quinine Sulphate BP are crucial for its pharmaceutical applications.
- Water: Freely soluble, making it ideal for oral and injectable formulations.
- Alcohol: Sparingly soluble.
- Acidic Solutions: Highly soluble, aiding in quick absorption and bioavailability.
- Organic Solvents: Partially soluble in some organic solvents like ether.
Due to its excellent solubility, Quinine Sulphate BP is widely used in liquid formulations for malaria treatment and muscle relaxation therapies.
Assay of Quinine Sulphate BP
The assay for Quinine Sulphate BP is conducted using High-Performance Liquid Chromatography (HPLC) to analyze purity and active content.
HPLC Assay Method for Quinine Sulphate BP
- 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 BP undergoes HPLC analysis to ensure it meets assay specifications, ensuring high purity and accurate dosage for pharmaceutical applications.
Chromatographic Purity by HPLC
The chromatographic purity of Quinine Sulphate BP 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 BP undergoes strict HPLC testing to ensure chromatographic purity, making it a safe and effective pharmaceutical ingredient.
Why Choose Prism Industries Pvt. Ltd. for Quinine Sulphate BP?
As a leading manufacturer of Quinine Sulphate BP, Prism Industries Pvt. Ltd. ensures:
✔ Pharmaceutical-Grade Purity: Meets BP, 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 Sulphate BP 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 BP, making it ideal for pharmaceutical applications.
For high-quality Quinine Sulphate BP, 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.