Hydroxychloroquine Sulphate is the sulfate salt of hydroxychloroquine, a 4-aminoquinoline derivative with antimalarial and immunomodulatory properties. It has been used in the treatment and management of malaria and certain autoimmune inflammatory disorders, subject to approved indications and local regulatory requirements.
Hydroxychloroquine Sulphate is a well-established pharmaceutical active ingredient used in the development and manufacture of oral solid dosage formulations.
Hydroxychloroquine Sulphate is a specialized pharmaceutical API requiring controlled synthesis, purification and stringent analytical testing. Quality evaluation generally focuses on identity, assay, related substances, sulfate content, residual solvents, water content and elemental impurities.
Consistent control of impurities and degradation products is particularly important for maintaining the quality and stability of pharmaceutical-grade Hydroxychloroquine Sulphate.
CAS Number: 747-36-4
Molecular Formula: C18H26ClN3O·H2SO4
Molecular Weight: 433.95 g/mol
Chemical Name: Hydroxychloroquine Sulfate
Drug Class: Antimalarial / Immunomodulatory Agent
Pharmacological Class: 4-Aminoquinoline Derivative
Therapeutic Class: Antimalarial / Antirheumatic
Therapeutic Area: Infectious Diseases / Rheumatology
Hydroxychloroquine accumulates within acidic intracellular compartments and interferes with processes associated with lysosomal and endosomal function.
Against malaria parasites, it interferes with heme detoxification, contributing to accumulation of toxic heme within the parasite.
Its immunomodulatory effects involve alteration of antigen processing and signaling pathways, which contributes to its use in selected autoimmune inflammatory conditions.
Hydroxychloroquine Sulphate is used in approved pharmaceutical formulations for conditions including:
The exact indications depend on the approved product labeling and regulations of the relevant country.
Hydroxychloroquine belongs to the 4-aminoquinoline class of antimalarial compounds. Its activity against susceptible malaria parasites is associated with interference in the parasite's handling of hemoglobin-derived heme.
Resistance to 4-aminoquinoline antimalarials occurs in some malaria parasites, so clinical use depends on the organism, geographic region and current treatment guidelines.
Hydroxychloroquine is also used as an immunomodulatory medicine in selected chronic inflammatory disorders. Its effects on intracellular immune signaling and antigen-processing pathways can reduce inflammatory activity.
Hydroxychloroquine Sulphate is generally supplied as a white or almost white crystalline powder. It is soluble in water and exhibits the characteristic properties of a sulfate salt of a 4-aminoquinoline derivative.
Hydroxychloroquine Sulphate API quality evaluation may include:
Hydroxychloroquine Sulphate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Storage requirements should follow validated stability data and the applicable product specification.
Hydroxychloroquine Sulphate remains relevant to pharmaceutical research involving 4-aminoquinoline chemistry, antimalarial pharmacology, lysosomal pathways and immunomodulation.
Hydroxychloroquine Sulphate is a 4-aminoquinoline pharmaceutical API with CAS Number 747-36-4, molecular formula C18H26ClN3O·H2SO4, and molecular weight approximately 433.95 g/mol. It has antimalarial and immunomodulatory properties and is used in approved formulations for malaria and selected autoimmune inflammatory disorders.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 3.0% |