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Lumefantrine IP/USP

Name: Lumefantrine IP/USP
Brand: PRISM INDUSTRIES PRIVATE LIMITED
Price: 2000.0 INR
Availability: InStock

Price 2000.0 INR/ Kilograms

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MOQ : 5 Kilograms

Lumefantrine IP/USP Specification

Taste
Bitter

Smell
Odorless

Color
Yellow

Loss on Drying
Not more than 0.5%

Melting Point
128-132°C

Storage
Store in a cool, dry, well-ventilated place; away from direct sunlight

Heavy Metal (%)
Not more than 0.001%

Particle Size
D90 < 15 microns

Poisonous
Non-poisonous under prescribed dosage

Structural Formula
Available on request

EINECS No
617-410-1

Molecular Weight
528.94 g/mol

Shelf Life
5 years

Solubility
Practically insoluble in water; soluble in methanol, ethanol, and dichloromethane

HS Code
29339900

Molecular Formula
C30H32Cl3NO

Medicine Name
Lumefantrine

Chemical Name
(RS)-2-(dibutylamino)-1-[(9Z)-2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl]ethanol

CAS No
82186-77-4

Type
Antimalarial Active Pharmaceutical Ingredient

Grade
IP/USP

Usage
For manufacturing of antimalarial drugs (Artemether-Lumefantrine combination)

Purity(%)
98.0% minimum

Appearance
Yellow crystalline powder

Physical Form
Solid

Certificate of Analysis
Available with each batch

Standard
Complies with IP/USP specifications

Specific Optical Rotation
Not applicable (racemic mixture)

Packing Size
25 kg / 50 kg

Impurity Level
Below 0.5%

Microbial Load
Complies with pharmacopoeial limits

Packaging Type
HDPE drums with double polyliner

Manufacturing Process
GMP certified facility

Residual Solvents
Complies with ICH guidelines

Identification
By IR, HPLC, and melting point

Lumefantrine IP/USP Trade Information

Minimum Order Quantity
5 Kilograms

FOB Port
ex our works

Payment Terms
Telegraphic Transfer (T/T), Letter of Credit (L/C), Cash in Advance (CID)

Supply Ability
500 Kilograms Per Month

Delivery Time
7 Days

Sample Policy
Contact us for information regarding our sample policy

Packaging Details
Standard export packing

Main Export Market(s)
Middle East, Africa, Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe

Main Domestic Market
, Daman and Diu, Goa, Jharkhand, Odisha, Assam, Delhi, West India, Meghalaya, All India, South India, Central India, North India, Gujarat, Karnataka, East India, Kerala, Andhra Pradesh, Punjab, Dadra and Nagar Haveli, Arunachal Pradesh, Lakshadweep, Mizoram, Manipur, Bihar, Chandigarh, Chhattisgarh, Haryana, Himachal Pradesh, Maharashtra, Telangana, Madhya Pradesh, Tamil Nadu, Uttarakhand, Andaman and Nicobar Islands, Jammu and Kashmir, Nagaland, Tripura, Pondicherry, Rajasthan, Sikkim, Uttar Pradesh, West Bengal

Certifications
GMP and ISO certified Plant

About Lumefantrine IP/USP

Lumefantrine Powder is used for the treatment of malaria and is generally prescribed in combination with artemether. It has chemical formula C30H32Cl3NO with molar mass of 528.939 g/mol. This compound is ideal for treating infections caused by Plasmodium falciparum and exerts its action against the erythrocytic stage. Lumefantrine Powder is known to be highly effective for infections acquired in chloroquine resistant areas. It is administered orally and has the ability to donate 1 and accept 2 hydrogen bonds.

Features:

It is known to have blood schizonticidal activity
Belongs to the group of arylamine alcohols
Has elimination half life of 4 to 6 days

High-Quality Manufacturing and Compliance

Our Lumefantrine is produced in India within a GMP-certified facility, ensuring adherence to global quality and safety standards. Each lot undergoes comprehensive testing, confirming compliance with IP and USP requirements, low impurity levels, and pharmacopoeial limits for residual solvents and microbial presence. This thorough process guarantees a reliable, high-quality API for antimalarial drug manufacturers.

Optimal Packaging and Stability

Lumefantrine is securely packed in HDPE drums equipped with a double polyliner, available in 25 kg and 50 kg sizes. This durable packaging safeguards the product against contamination and environmental factors, maintaining its efficacy and stability. The product should be stored in a cool, dry, well-ventilated area away from direct sunlight to preserve its 5-year shelf life.

Benefits for Pharmaceutical Development

Lumefantrines proven performance in combination therapies, notably with Artemether, makes it the preferred API in contemporary antimalarial drug manufacturing. Its outstanding purity, low impurity and heavy metal content, and strict compliance with international standards contribute to safer and more effective pharmaceutical preparations.

FAQs of Lumefantrine IP/USP:

Q: How is the quality of Lumefantrine ensured during manufacturing?

A: Lumefantrine is manufactured in a GMP-certified facility, following strict quality protocols. Each batch undergoes testing for identity (IR, HPLC, and melting point), impurity levels, microbial load, and residual solvents to fulfill IP/USP requirements. A Certificate of Analysis is provided with every shipment.

Q: What is the recommended storage condition for Lumefantrine to maximize shelf life?

A: To maintain stability, Lumefantrine should be stored in a cool, dry, and well-ventilated location, protected from direct sunlight. Proper storage preserves its quality and ensures a shelf life of up to five years.

Q: When is Lumefantrine used in pharmaceutical manufacturing?

A: Lumefantrine serves as the active pharmaceutical ingredient in antimalarial drug formulations, particularly in combination with Artemether. It is used during the drug manufacturing phase to produce effective therapies against malaria.

Q: Where is Lumefantrine manufactured and supplied from?

A: Lumefantrine is manufactured in India and is available for export and import globally. It is supplied by reputed manufacturers, exporters, and suppliers, meeting international regulatory standards.

Q: What benefits does Lumefantrine offer to pharmaceutical companies?

A: Pharmaceutical firms benefit from Lumefantrines high purity (98.0%), low impurity and heavy metal content, reliable pharmaceutical compliance, and extended shelf life, ensuring consistency, safety, and efficacy in antimalarial drug products.

Q: What is the appearance and solubility profile of Lumefantrine?

A: Lumefantrine appears as a yellow crystalline powder and is practically insoluble in water, but dissolves well in methanol, ethanol, and dichloromethane. This solubility profile supports its application in pharmaceutical formulations.

Q: How is Lumefantrine packaged for shipment and handling?

A: The API is packed in robust HDPE drums with a double polyliner for maximum protection. Standard packing sizes are 25 kg and 50 kg, ensuring the material stays uncontaminated and stable during transit and storage.

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