Primaquine Phosphate is a pharmaceutical-grade active pharmaceutical ingredient (API) belonging to the 8-aminoquinoline class of antimalarial compounds. It is the phosphate salt of primaquine and is widely used in the pharmaceutical industry for the development and manufacture of antimalarial medicines. Primaquine Phosphate is particularly important in preventing relapse associated with Plasmodium vivax and Plasmodium ovale malaria.
Primaquine Phosphate is also known as Primaquine Diphosphate and is identified by CAS Number 63-45-6. It has the molecular formula C15H27N3O9P2 and a molecular weight of 455.34 g/mol.
Primaquine Phosphate is a synthetic 8-aminoquinoline derivative formulated as the diphosphate salt of primaquine. Its pharmaceutical importance is associated with activity against the liver stages of susceptible malaria parasites. The API is suitable for pharmaceutical formulation and development of oral antimalarial dosage forms.
The material is generally described as an orange-red to reddish crystalline powder. It is soluble in water and has limited solubility in ethanol and ether. Appropriate protection from light, moisture, and environmental contamination is important during storage and handling.
Primaquine Phosphate has the following chemical characteristics:
It is important to distinguish Primaquine Phosphate from the parent Primaquine compound because their CAS numbers, molecular formulas, and molecular weights are different.
Primaquine Phosphate is primarily used as an API for antimalarial pharmaceutical products. Its principal therapeutic significance is associated with preventing relapse of Plasmodium vivax and Plasmodium ovale malaria following appropriate treatment of the blood-stage infection.
Its pharmaceutical applications include:
The use and dosage of Primaquine Phosphate in finished medicines should follow the applicable approved product information and regulatory requirements.
Quality testing of Primaquine Phosphate API is performed to establish identity, assay, purity, and consistency. Pharmaceutical-grade material can be evaluated against applicable pharmacopoeial requirements and approved specifications.
Analytical testing may include:
The USP monograph specifies 97.0% to 102.0% Primaquine Phosphate on the dried basis. USP also specifies identification procedures and a loss on drying limit of NMT 1.0% when dried at 105°C for 2 hours.
Primaquine Phosphate API manufacturing involves controlled processing, qualified raw materials, purification, drying, analytical testing, and documented quality-control procedures. Consistent manufacturing controls are important for achieving reproducible API quality suitable for pharmaceutical formulation.
A pharmaceutical manufacturing process for Primaquine Phosphate may involve:
Primaquine Phosphate API can be manufactured according to applicable pharmacopoeial requirements, regulatory expectations, and customer-specific specifications.
Primaquine Phosphate should be stored in a well-closed container and protected from light and moisture. Suitable pharmaceutical packaging should minimize exposure to environmental contaminants during storage and transportation.
Storage conditions should be established according to applicable stability data and the approved product specification. Proper handling and controlled environmental conditions help maintain the quality and physical characteristics of the API.
The documentation available for Primaquine Phosphate API may include:
A reliable Primaquine Phosphate API manufacturing source should maintain appropriate manufacturing controls, analytical testing, documentation, and batch traceability. Consistent quality management supports pharmaceutical companies involved in antimalarial formulation development and commercial manufacturing.
Primaquine Phosphate, CAS Number 63-45-6, remains an important pharmaceutical API for antimalarial applications. Quality-focused manufacturing, validated analytical testing, appropriate packaging, and comprehensive documentation are essential for maintaining consistent API quality.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |