Pharmacy Grade API Artesunate 99% CP BP USP EP Standard White Raw Power With Fast Delivery

Propylparaben More Info

Chemical Profile and Therapeutic Class

Artesunate (CAS 88495-63-0) is a semi-synthetic sesquiterpene lactone derivative of artemisinin, specifically designed as a water-soluble prodrug for enhanced bioavailability. As a key member of the artemisinin-based combination therapies (ACTs) recommended by WHO, it belongs to the class of rapid-acting antimalarials that target the erythrocytic stage of Plasmodium parasites. Its molecular structure incorporates a succinate moiety that enables solubility for parenteral administration while maintaining the crucial endoperoxide bridge essential for its mechanism of action.

Mechanism of Action and Parasiticidal Activity

The compound's antimalarial activity centers on its endoperoxide bridge, which undergoes iron-mediated cleavage within the parasite's digestive vacuole, generating cytotoxic carbon-centered radicals and reactive oxygen species. These reactive intermediates cause extensive damage to parasitic proteins, membranes, and organelles, leading to rapid parasite clearance. Artesunate demonstrates exceptional potency against all Plasmodium species, including chloroquine-resistant strains, with parasite reduction ratios significantly superior to other antimalarial classes.

Clinical Applications and Treatment Protocols

Artesunate serves as first-line therapy for severe malaria in both adults and children, administered via intravenous or intramuscular routes in hospital settings. For uncomplicated malaria, it is formulated in fixed-dose combinations with longer-acting partner drugs such as amodiaquine or mefloquine. The World Health Organization recommends artesunate-based combinations as first-line treatment for P. falciparum malaria across all endemic regions. Emerging applications include investigational use in cancer therapy and other parasitic infections, leveraging its potent cytotoxic mechanisms.

Formulation Spectrum and Administration Routes

We supply artesunate active pharmaceutical ingredient suitable for multiple dosage forms including lyophilized powder for injectable solutions, oral tablets, and rectal suppositories. The injectable form requires reconstitution with phosphate buffer to achieve optimal stability and bioavailability. Our technical data supports development of both immediate-release and combination tablets, with specific guidance on stabilization techniques to prevent degradation in tropical climates.

Quality Standards and Analytical Controls

Our artesunate API complies with International Pharmacopoeia specifications and WHO prequalification requirements, with rigorous control of critical quality attributes including artesunate content (98.0-102.0%), related substances (particularly dihydroartemisinin), residual solvents, and heavy metals. We employ validated HPLC-UV methods for identity confirmation and potency determination, with strict limits set for degradation products to ensure product stability throughout the shelf life.

Safety Profile and Contraindications

Artesunate is generally well-tolerated, with the most common adverse effects being transient nausea, vomiting, and reticulocytopenia. The compound carries precautions regarding first-trimester pregnancy due to embryonic toxicity observed in animal studies. Post-marketing surveillance has identified rare cases of allergic reactions and neurological abnormalities following very high doses. Appropriate warnings include monitoring for hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.

Stability Considerations and Storage Requirements

The API requires protection from moisture, light, and oxidative degradation, with recommended storage in sealed containers under inert atmosphere at 2-8°C. Formulation strategies must address the compound's sensitivity to hydrolysis, particularly in tropical conditions, through appropriate excipient selection and packaging. Our stability studies demonstrate 36-month shelf life when proper storage conditions are maintained, with comprehensive data available to support regulatory submissions.

Global Health Impact and Market Position

Artesunate occupies a critical position in global malaria control programs, with production volumes steadily increasing to meet WHO elimination targets. The market is characterized by strong demand from both public health procurement agencies and private sector distributors in endemic regions. As patent protections have expired, robust generic competition has emerged, though quality variation remains a concern that our stringent manufacturing standards directly address.

Regulatory Status and Prequalification

Our manufacturing facilities maintain WHO prequalification status and comply with PIC/S GMP standards, supporting regulatory approvals in malaria-endemic countries and stringent regulatory authorities. We provide complete regulatory documentation including Drug Master Files, Certificate of Pharmaceutical Product, and supporting stability data to facilitate customer registrations. The compound is listed in the WHO Model List of Essential Medicines and approved by over 80 national regulatory authorities.

Supply Chain Capabilities and Partnership Models

We maintain a secure supply chain from artemisinin extraction through to finished API, with dual sourcing strategies for key starting materials to ensure continuity of supply. Our partnership models include tiered pricing for global health procurement, technical transfer services for formulation development, and collaborative research on next-generation artemisinin derivatives. We actively support anti-counterfeiting initiatives through product authentication technologies and supply chain transparency measures.

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FAQ

Q1. Can I get a free sample?

We can send you a samll free sample, and you only need to pay for the shipping cost.

Q2. What is the HyperChem payment term?

T/T in advance
LC at sight
DP at sight

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Q3. What is HyperChem shipment policy?

Our policy is to strive for the quickest shipment time possible.

For ready stock samples, they are usually shipped within 3 working days after payment received.
For non-ready stock, please contact HyperChem sales team to negotiate.

Q4. What is HyperChem shipment term?

By Express  
FedEx  UPS  DHL  EMS                               
Fast: 3-7 days around, high cost, door to door service

By Air                                        
Suitable for more than 50kg 
Fast: 3-7 days, hight cost, port to port, professional broker needed 

By Sea
Suitable for more than 500kg      
Fast: 7-45 days, low cost, port to port, professional broker needed 

We will always attempt to utilize the quickest and most affordable way for customers to receive orders. And follow -up with customers via email for all shipment details as well as updated track information until it arrives without damage.

Q5. What HyperChem will provide after shipment?

For sample orders: 
After shipment is done, an timely email including:

1. Track details (Fedex /TNT/DHL/EMS Track number)
2. Packaging photo
3. COA, MSDS, etc
4. Dispatch date & Estimated arriving time
5. Shipping invoice

For commercial orders
A full set of shipment documents as well as package photos can be provided in scan-copy and original, to help customers complete the customs clearance process.

Company Profile

Established in 2013, Hyper Chem has exclusive tie-ups with leading manufacturers, supplying raw materials produced in GMP and ISO 9002 certified facilities, and provides high-quality ingredients and raw materials to cater to the requirements of our diverse range of clients.

Among them, our key client industrial sectors around the global are:

Pharmaceuticals
Nutrition Ingredients/ Dietary supplements
Cosmetic Ingredients
Food Ingredients
Veterinary API
Agriculture fertilizer
Custom Synthesis lab supply

HyperChem provides to its wonderful and honorable clients comprehensive purchasing and distribution services which ensure that we are delivering the right generic, raw, or customized product, make sure that we are delivering it at the right time, ensure that it is delivered in the specified amount, and in the right kind of packaging to clients and customers of all types of industries irrespective of their size of operation.