Description

Primaquine Diphosphate is a synthetic antimalarial agent belonging to the 8-aminoquinoline class. Its primary commercial value lies in its critical role as the definitive treatment for the dormant liver stages (hypnozoites) of *Plasmodium vivax* and *Plasmodium ovale* malaria, preventing relapses. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry producing anti-malarial medications, particularly for radical cure protocols in endemic regions.

Application

• Pharmaceutical API: Primary use as the active ingredient in tablet formulations for the radical cure of P. vivax and P. ovale malaria.
• Combination Therapy: Used in conjunction with other antimalarials like chloroquine or artemisinin-based compounds for comprehensive treatment regimens.
• Clinical Research: Serves as a reference standard and key component in studies investigating new malaria treatment protocols and drug resistance.
• GMP Manufacturing: Supplied to certified facilities for the production of finished dosage forms under Good Manufacturing Practice guidelines.
• Public Health Programs: Integral to medicines procured for national and international malaria control and elimination initiatives.

Basic Information

Product Name	Primaquine Diphosphate
CAS No.	63-45-6
Molecular Formula	C₁₅H₂₁N₃O · 2H₃PO₄
Molecular Weight	455.34 g/mol
Synonyms	Primaquine Phosphate; Primaquine Bis(phosphate); 8-[(4-Amino-1-methylbutyl)amino]-6-methoxyquinoline Diphosphate; SN 13272; NSC 143164; Primaquine Acid Phosphate
EINECS	Contact for details

Quality Control

Our Primaquine Diphosphate is manufactured and tested to meet stringent pharmaceutical standards. Quality assurance includes comprehensive analytical testing for identity, purity, and impurities, aligning with pharmacopeial guidelines. A Certificate of Analysis (COA) detailing batch-specific results for assay, related substances, residual solvents, and microbiological attributes is provided with each shipment to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
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.