Iguratimod is a synthetic disease-modifying antirheumatic drug (DMARD) and active pharmaceutical ingredient used primarily in the treatment of rheumatoid arthritis. It belongs to a distinctive class of small-molecule anti-inflammatory and immunomodulatory compounds.
Iguratimod has the molecular formula C17H14N2O6S and a molecular weight of approximately 374.37 g/mol. Its CAS Number is 123176-24-3.
Iguratimod is an orally active synthetic compound developed for the management of rheumatoid arthritis. It has anti-inflammatory and immunomodulatory effects and can reduce the production of several inflammatory mediators.
It is used as a disease-modifying antirheumatic drug in certain markets, particularly in Japan and China, either as monotherapy or in combination with other antirheumatic therapies.
Iguratimod suppresses inflammatory and immune responses involved in rheumatoid arthritis. It has been reported to inhibit the production of inflammatory cytokines and immunoglobulins and to influence the activity of immune cells.
Its pharmacological effects include suppression of B-cell immunoglobulin production and reduction of inflammatory mediators such as interleukin-6 (IL-6).
Iguratimod API is used in the development and manufacture of:
Iguratimod is manufactured through controlled chemical synthesis followed by purification, crystallization and drying. Pharmaceutical quality testing is performed to verify identity, potency, purity and other critical quality attributes.
Quality control may include identification, assay, related substances, water content, residue on ignition, elemental impurities and residual solvents according to the applicable approved specification.
Iguratimod is generally supplied as a white to off-white crystalline powder. It has limited solubility in water and is more soluble in certain organic solvents.
Iguratimod 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:
Iguratimod is a synthetic immunomodulatory DMARD used primarily in rheumatoid arthritis. Its anti-inflammatory and immune-modulating properties make it an important active ingredient for the development of oral pharmaceutical products targeting inflammatory joint diseases.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 238–242°C |