Fingolimod Hydrochloride (Fingolimod HCl) is the hydrochloride salt of fingolimod and is a synthetic active pharmaceutical ingredient belonging to the sphingosine-1-phosphate receptor modulator class. It is associated with immunomodulatory activity and pharmaceutical formulations used for 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 identified as a white pharmaceutical/reference-standard powder or solid.
Fingolimod Hydrochloride is used as an active pharmaceutical ingredient in formulations associated with the management of relapsing forms of multiple sclerosis. Fingolimod acts through modulation of sphingosine-1-phosphate receptors and has immunomodulatory effects.
Fingolimod is phosphorylated to its active phosphate form, which interacts with sphingosine-1-phosphate receptors. This mechanism contributes to modulation of lymphocyte trafficking and its immunomodulatory pharmaceutical activity.
Fingolimod Hydrochloride can be evaluated using analytical techniques such as:
USP provides an official monograph for Fingolimod Hydrochloride and specifies 98.0–102.0% content 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 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |