Hydroxychloroquine Sulfate is a 4-aminoquinoline derivative and an active pharmaceutical ingredient with antimalarial and immunomodulatory properties. It is the sulfate salt of hydroxychloroquine and has been used in pharmaceutical formulations for malaria and certain autoimmune diseases.
Hydroxychloroquine Sulfate has the molecular formula C18H26ClN3O·H2SO4 and a molecular weight of 433.95 g/mol. Its CAS Number is 747-36-4.
Hydroxychloroquine Sulfate is a synthetic derivative of chloroquine developed to provide antimalarial activity with a different safety and pharmacological profile. It is used in pharmaceutical products for the treatment and prevention of malaria and in the management of selected autoimmune disorders.
The compound is generally supplied as the sulfate salt to provide a stable pharmaceutical form suitable for formulation.
Hydroxychloroquine accumulates within acidic intracellular compartments such as lysosomes and endosomes. Its antimalarial activity is associated with interference with parasite heme metabolism.
Its immunomodulatory effects involve alteration of intracellular processing and signaling pathways, including effects on antigen presentation and toll-like receptor signaling.
Hydroxychloroquine Sulfate API is used in the development and manufacture of:
Hydroxychloroquine Sulfate is manufactured through controlled chemical synthesis followed by purification, salt formation, drying and pharmaceutical quality testing.
Quality control may include identity, assay, related substances, water content, residue on ignition, elemental impurities and residual solvents according to the applicable pharmacopoeial or approved manufacturer specification.
Hydroxychloroquine Sulfate is generally supplied as a white or almost white crystalline powder. It is soluble in water and has the characteristic properties of a sulfate salt of a basic 4-aminoquinoline compound.
Hydroxychloroquine Sulfate should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Hydroxychloroquine Sulfate is an established 4-aminoquinoline pharmaceutical ingredient with antimalarial and immunomodulatory properties. Its defined chemical characteristics and established pharmaceutical applications make it an important API for antimalarial and autoimmune-disease formulations.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 3.5 – 5.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 3.0% |
| Melting Point | Approximately 240°C (decomposition) |