Description

Tafenoquine is a synthetic 8-aminoquinoline derivative, recognized as a potent antimalarial agent for the prevention of relapse caused by *Plasmodium vivax* and *Plasmodium ovale*. Its primary commercial value lies in providing a single-dose radical cure and prophylaxis, offering a significant logistical advantage over traditional multi-day regimens. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing next-generation antimalarial formulations for global health initiatives and travel medicine.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the radical cure (prevention of relapse) of *P. vivax* and *P. ovale* malaria.
• Prophylactic Treatment: Formulated for the prevention of malaria in travelers and military personnel to endemic regions, benefiting from its long half-life.
• Combination Therapy Development: Serves as a key component in research and development of novel fixed-dose combination therapies to combat drug resistance.
• Clinical Research Material: Used as a reference standard and raw material in preclinical and clinical studies investigating new treatment protocols.
• GMP Manufacturing: Supplied to certified contract manufacturing organizations (CMOs) for the production of finished dosage forms (e.g., tablets).

Basic Information

Product Name	Tafenoquine
CAS No.	106635-80-7
Molecular Formula	C24H28F3N5O3
Molecular Weight	491.50 g/mol
Synonyms	SB-252263; Tafenoquine Succinate (salt form); WR 238605; Etaquine; (R,S)-Tafenoquine; 8-[(4-Amino-1-methylbutyl)amino]-2,6-dimethoxy-4-methyl-5-(3-trifluoromethylphenoxy)quinoline
EINECS	Contact for details

Quality Control

Our Tafenoquine is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. Comprehensive testing includes assay, related substances, residual solvents, and microbiological limits. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry, well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.