Product Description
Quinine Sulphate USP is a pharmaceutical-grade active pharmaceutical ingredient (API) widely used for the treatment of malaria, nocturnal leg cramps, and muscle disorders. It is a natural alkaloid derived from Cinchona bark, known for its antimalarial, analgesic, and muscle relaxant properties.
At Prism Industries Pvt. Ltd., we specialize in the production of high-purity Quinine Sulphate USP, ensuring compliance with United States Pharmacopeia (USP) standards. Our Quinine Sulphate USP undergoes strict quality control to ensure high efficacy, safety, and purity for pharmaceutical use.
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 to slightly yellow crystalline powder
- Odor: Odorless or slightly bitter odor
- Solubility: Freely soluble in water, slightly soluble in alcohol
- Function: Used as an antimalarial agent, muscle relaxant, and fever reducer
Quinine Sulphate USP is recognized for its effectiveness against malaria, particularly against Plasmodium falciparum infections. It is also used in pharmaceutical formulations for muscle relaxation and pain relief.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that our Quinine Sulphate USP meets international regulatory standards. We provide the following regulatory documents for compliance and safety:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with USP specifications.
- Material Safety Data Sheet (MSDS): Details safety measures, handling, and storage information.
- Good Manufacturing Practices (GMP) Certificate: Ensures manufacturing under strict quality-controlled environments.
- United States Pharmacopeia (USP) Compliance: Adheres to USP specifications for pharmaceutical-grade Quinine Sulphate.
- TSE/BSE-Free Statement: Certifies that the product contains no animal-derived components.
- Stability Data Report: Provides information on long-term stability under different storage conditions.
- Residual Solvents Report: Ensures compliance with ICH Q3C guidelines for safe solvent levels.
- Allergen-Free Statement: Confirms that the product is free from allergens.
Our commitment to regulatory compliance ensures that Quinine Sulphate USP meets stringent industry standards, making it a safe and effective API for pharmaceutical applications.
Specifications of Quinine Sulphate USP
Our Quinine Sulphate USP is manufactured under strict quality control measures, 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, slightly 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 USP standards |
The high purity and strict compliance of our Quinine Sulphate USP make it ideal for pharmaceutical formulations and medical use.
Solubility of Quinine Sulphate USP
The solubility properties of Quinine Sulphate USP play an essential role in its pharmaceutical applications.
- Water: Freely soluble, making it ideal for oral and injectable formulations.
- Alcohol: Slightly soluble.
- Acidic Solutions: Highly soluble, allowing for quick absorption in the body.
- Organic Solvents: Partially soluble in some organic solvents like ether.
Due to its excellent solubility, Quinine Sulphate USP is widely used in liquid formulations for malaria treatment and muscle relaxant therapies.
Assay of Quinine Sulphate USP
The assay for Quinine Sulphate USP is performed using High-Performance Liquid Chromatography (HPLC) to analyze purity and active content.
HPLC Assay Method for Quinine Sulphate USP
- 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 USP undergoes HPLC analysis to ensure it meets assay specifications, guaranteeing high purity and correct dosage for pharmaceutical applications.
Chromatographic Purity by HPLC
The chromatographic purity of Quinine Sulphate USP 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 USP 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 USP?
As a leading manufacturer of Quinine Sulphate USP, Prism Industries Pvt. Ltd. ensures:
Pharmaceutical-Grade Purity: Meets USP, 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 USP 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 USP, making it ideal for pharmaceutical applications.
For high-quality Quinine Sulphate USP, 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.