Product Description
Quinine Sulphate EP is a high-purity pharmaceutical active ingredient (API) used primarily for the treatment of malaria, muscle cramps, and fever reduction. It is derived from the Cinchona bark, a natural source of quinoline alkaloids.
At Prism Industries Pvt. Ltd., we manufacture Quinine Sulphate EP under strict compliance with the European Pharmacopoeia (EP) standards. Our Quinine Sulphate EP undergoes rigorous quality testing and regulatory compliance, ensuring safety, efficacy, and purity for pharmaceutical 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, 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 EP is highly effective in treating malaria, particularly against Plasmodium falciparum infections. It is also used in pharmaceutical formulations to relieve muscle cramps and fevers.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that our Quinine Sulphate EP meets international regulatory standards. We provide the following regulatory documents to ensure compliance, safety, and traceability:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with EP standards.
- Material Safety Data Sheet (MSDS): Details safety, handling, and storage guidelines.
- Good Manufacturing Practices (GMP) Certificate: Ensures high-quality pharmaceutical production.
- European Pharmacopoeia (EP) Compliance: Meets EP specifications for pharmaceutical-grade Quinine Sulphate.
- TSE/BSE-Free Statement: Confirms the absence of animal-derived components.
- Stability Data Report: Provides long-term stability data under various 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 EP meets pharmaceutical industry standards, making it a safe and effective API for drug formulations.
Specifications of Quinine Sulphate EP
Our Quinine Sulphate EP 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 EP standards |
The high purity and strict compliance of our Quinine Sulphate EP make it ideal for pharmaceutical formulations and therapeutic use.
Solubility of Quinine Sulphate EP
The solubility properties of Quinine Sulphate EP play a key role in its pharmaceutical applications.
- Water: Freely soluble, making it ideal for oral and injectable formulations.
- Alcohol: Sparingly 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 high solubility, Quinine Sulphate EP is widely used in liquid formulations for malaria treatment and muscle relaxant therapies.
Assay of Quinine Sulphate EP
The assay for Quinine Sulphate EP is conducted using High-Performance Liquid Chromatography (HPLC) to analyze purity and active content.
HPLC Assay Method for Quinine Sulphate 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 Sulphate EP 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 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 Sulphate EP 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 EP?
As a leading manufacturer of Quinine Sulphate 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 Sulphate 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 Sulphate EP, making it ideal for pharmaceutical applications.
For high-quality Quinine Sulphate 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.