Fingolimod Hydrochloride is a synthetic active pharmaceutical ingredient belonging to the sphingosine-1-phosphate (S1P) receptor modulator class. It is the hydrochloride salt of fingolimod and is used in pharmaceutical formulations associated with the treatment of relapsing forms of multiple sclerosis.
Fingolimod Hydrochloride has the molecular formula C₁₉H₃₄ClNO₂, molecular weight 343.93 g/mol, and CAS Number 162359-56-0. It is characterized as a white to off-white solid and is used as an active pharmaceutical ingredient in pharmaceutical development and manufacturing.
Fingolimod Hydrochloride is primarily used in pharmaceutical formulations for relapsing forms of multiple sclerosis. Fingolimod is phosphorylated in the body to its active phosphate form, which interacts with sphingosine-1-phosphate receptors and produces immunomodulatory effects.
Fingolimod phosphate interacts with sphingosine-1-phosphate receptors and modulates lymphocyte trafficking. This contributes to the reduction of circulating lymphocytes available to participate in inflammatory processes.
Fingolimod Hydrochloride can be evaluated using analytical techniques including:
USP specifies Fingolimod Hydrochloride at 98.0%–102.0% on an anhydrous and solvent-free basis.
| 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% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |