Product Description
Lumefantrine USP is a high-quality pharmaceutical-grade antispasmodic agent used to relieve smooth muscle spasms in the gastrointestinal, urinary, and biliary tracts. It is commonly prescribed to treat irritable bowel syndrome (IBS), renal colic, and painful cramps by relaxing the muscles of the digestive system.
Unlike other antispasmodics, Lumefantrine USP does not cross the blood-brain barrier, making it an effective choice with minimal central nervous system (CNS) side effects. It is available in tablet, injectable, and oral liquid formulations, providing rapid and long-lasting relief.
At Prism Industries Pvt. Ltd., we manufacture high-purity Lumefantrine USP, ensuring compliance with United States Pharmacopeia (USP) standards standards. Our strict quality control ensures that each batch meets the highest pharmaceutical safety and efficacy criteria.
Identification
- Chemical Name: Lumefantrine
- Molecular Formula: C21H30BrNO4
- Molecular Weight: 440.37 g/mol
- CAS Number: [Specific CAS Number]
- Synonyms: Scopolamine Hydrobromide, Butylscopolamine
- Appearance: White or almost white crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water, slightly soluble in alcohol
- Function: Used as an antispasmodic agent to relieve smooth muscle spasms in the digestive, urinary, and biliary tracts.
Lumefantrine USP is widely used in pharmaceutical formulations to provide fast and effective relief from muscle cramps and spasms.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that Lumefantrine USP meets global regulatory standards and provide the following regulatory documents:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with USP 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.
- United States Pharmacopeia (USP) standards 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 Lumefantrine USP meets the highest quality and safety standards for pharmaceutical formulations.
Specifications of Lumefantrine USP
Our Lumefantrine USP is manufactured under strict quality control conditions, meeting the following pharmaceutical specifications:
Parameter | Specification |
Appearance | White or almost white crystalline powder |
Odor | Odorless |
Identification | Positive for Lumefantrine |
Melting Point | 138°C – 142°C |
Solubility | Freely soluble in water, slightly soluble in alcohol |
pH (5% Solution in Water) | 5.0 – 7.0 |
Assay (Purity by HPLC) | 98.0% – 102.0% |
Loss on Drying | ≤ 1.0% |
Heavy Metals | ≤ 10 ppm |
Residual Solvents | Complies with ICH Q3C guidelines |
Microbial Limits | Complies with USP standards |
Our Lumefantrine USP meets strict pharmaceutical standards, ensuring its purity, consistency, and safety for medical and research applications.
Solubility of Lumefantrine USP
- Water: Freely soluble, making it ideal for injectable and liquid formulations.
- Alcohol: Slightly soluble.
- Acidic Solutions: Highly soluble, ensuring quick absorption in the body.
- Organic Solvents: Partially soluble in some organic solvents like chloroform.
Due to its high water solubility, Lumefantrine USP is widely used in oral, injectable, and topical formulations for rapid therapeutic action.
Assay of Lumefantrine USP
The assay of Lumefantrine USP is performed using High-Performance Liquid Chromatography (HPLC) to ensure purity and potency.
HPLC Assay Method for Lumefantrine 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%
Chromatographic Purity by HPLC
- 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%
Lumefantrine USP is a highly effective antispasmodic agent with excellent solubility, purity, and stability. At Prism Industries Pvt. Ltd., we ensure top-quality production, regulatory compliance, and superior quality control for Lumefantrine USP, making it ideal for pharmaceutical applications.
For high-quality Lumefantrine USP, contact us today for bulk supply and customized pharmaceutical solutions.
FAQs:
Lumefantrine USP is a Pharma Grade Active Pharmaceutical Ingredient (API) in adherence with the quality specifications of USP (United States Pharmacopeia). It serves as a core component in various anti-malarial drugs, often used in combination drugs to cure the malaria disease.
Yes. Prism Industries is the manufacturer of Lumefantrine USP in aWHO-GMP facility and works in strict adherence to its established Quality Management Systems. Rigorous in-process checks and final product testing are performed on all batches to conform to pharmacopoeial requirements and to international quality standards.
Each batch undergoes comprehensive quality testing, including identity, assay, purity, related substances, residual solvents, moisture content, and other analytical evaluations using validated laboratory methods to ensure consistent pharmaceutical quality.
Prism Industries will deliver such quality documentation as a Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), product specifications, or any other product quality documents needed for pharmaceutical manufacturing and related regulatory needs.
Yes, Prism Industries has the ability to produce bulk quantities of Lumefantrine USP to serve the requirements of pharmaceutical manufacturing firms, contract manufacturers and world distributors while guaranteeing timely supply and guaranteed quality.
To ensure the stability of the product, Lumefantrine USP will be provided in tamper-proof pharmaceutical packaging for transit and warehousing. Packaging can be arranged as required by our customers and commercial production requirements.
Through extensive 30+ years in pharmaceutical manufacturing experience, a production unit that is certified WHO-GMP compliant, cutting-edge QC Labs and sound regulatory assistance, Prism Industries offers you excellent quality Lumefantrine USP that has excellent batch-to-batch reliability.
Yes, Prism Industries is exporting pharma APIs in various countries and also provides required quality documentation and regulatory support in line with global requirement of customer
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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.