Lumefantrine Active Pharmaceutical Ingredients

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Lumefantrine Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Lumefantrine Active Pharmaceutical Ingredients Specification

HS Code
29336990

Shelf Life
36 months

Smell
Odorless

Particle Size
D90 < 10 microns (typical)

Molecular Formula
C30H32Cl3NO

Loss on Drying
Not more than 0.5%

Heavy Metal (%)
Not more than 0.001%

Poisonous
Non-poisonous as a raw material, used under prescription only

Color
Yellow

Solubility
Practically insoluble in water; soluble in dichloromethane, slightly soluble in acetonitrile

Structural Formula
C30H32Cl3NO (as depicted in product documentation)

Storage
Store in a cool, dry place, protected from light

Melting Point
130-132C

Molecular Weight
528.94 g/mol

EINECS No
617-527-0

Medicine Name
Lumefantrine

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

CAS No
82186-77-4

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the treatment of malaria, typically in combination with artemether

Purity(%)
Not less than 98.0%

Appearance
Yellow crystalline powder

Physical Form
Solid

Sulphated Ash
Not more than 0.1%

Manufacturing Process
Non-GMO, complies with cGMP

Chloride Content
Not more than 0.1%

Microbial Limits
Bacterial endotoxins: Not more than 0.5 EU/mg

Residual Solvents
Within ICH limits

Packaging
Double polyethylene bags in HDPE drums, 5kg/10kg/25kg

Related Substances
Total impurities: Not more than 1.0%

Identification
Complies with reference standard by IR and HPLC

Specific Optical Rotation
+46 to +50 (in methanol)

Lumefantrine Active Pharmaceutical Ingredients Trade Information

Minimum Order Quantity
25 Kilograms

Payment Terms
Cash in Advance (CID), Cash on Delivery (COD), Cash Against Delivery (CAD)

Supply Ability
500 Kilograms Per Month

Delivery Time
5-7

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

Main Domestic Market
All India

About Lumefantrine Active Pharmaceutical Ingredients

Utilise our exclusive Discount on Lumefantrine Active Pharmaceutical Ingredients-crafted for an enlightened standard of purity and compliance. This rarefied, pharmaceutical-grade API is verified for exceptional quality: Residual Solvents are within ICH limits, with Chloride and Sulphated Ash each not exceeding 0.1%. Lustrous in its yellow crystalline solid form, its robust manufacturing abides by cGMP and Non-GMO protocols, ensuring safe, effective results. Personalise your procurement with packaging options of 5kg, 10kg, or 25kg HDPE drums, delivered securely for optimal shelf life and stability.

Lumefantrine API: Special Features and Applications

Lumefantrine Active Pharmaceutical Ingredients offer rarefied purity with a minimum 98% assay, minimal impurities, and robust compliance to stringent standards. Utilised primarily in antimalarial formulations, it is typically combined with artemether in oral dosage forms. The lustrous yellow powder handles effortlessly, thanks to its ideal particle size and solubility profile, optimising drug development and patient outcomes. This API may also spark interest in research for novel combination therapies, supported by its stability and high-grade characteristics.

FOB Port, Payment, and Export Market for Lumefantrine API

The valuation of Lumefantrine API is competitive, offering added value for traders and suppliers worldwide. Goods are shipped from major Indian FOB ports, leveraging streamlined goods transport to ensure safe, timely arrivals. Various payment terms, including LC and TT, are accepted for client flexibility. The main export markets span Asia, Africa, and Latin America, providing access to high-demand regions while upholding reliable logistics and international compliance throughout the export process.

FAQ's of Lumefantrine Active Pharmaceutical Ingredients:

Q: How is Lumefantrine API typically used in pharmaceutical manufacturing?

A: Lumefantrine API is mainly utilised in combination with artemether to formulate antimalarial medications. These combinations are designed for oral administration, targeting effective malaria treatment.

Q: What are the unique special features of Lumefantrine API provided by your company?

A: Our Lumefantrine API demonstrates rarefied purity (not less than 98%), compliance with cGMP and ICH standards, low impurity profile, controlled microbial limits, and flexible packaging in HDPE drums for client convenience.

Q: Where is the product shipped from, and who are the main export markets?

A: Lumefantrine API is shipped from major Indian ports, reaching export markets in Asia, Africa, and Latin America, supported by reliable transport networks.

Q: What is the typical shelf life and recommended storage conditions for Lumefantrine API?

A: The shelf life of Lumefantrine API is 36 months when stored in a cool, dry place away from light, ensuring its quality and potency remain intact.

Q: How is the identity and quality of Lumefantrine API assured?

A: Identification is conducted using IR and HPLC methods, with strict quality controls for residual solvents, impurities, and microbial contamination to ensure pharmaceutical-grade standards are met.

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