Fingolimod is a sphingosine-1-phosphate (S1P) receptor modulator used as an immunomodulatory pharmaceutical ingredient. Fingolimod is available in pharmaceutical products primarily in its hydrochloride salt form, Fingolimod Hydrochloride (Fingolimod HCl). It is associated with the treatment of relapsing forms of multiple sclerosis.
Fingolimod Hydrochloride is a synthetic active pharmaceutical ingredient characterized by the molecular formula C₁₉H₃₃ClNO₂ and molecular weight 343.93 g/mol. It is described as a white to off-white crystalline powder and is freely soluble in water.
Swapproop provides pharmaceutical API information and sourcing support for Fingolimod and Fingolimod Hydrochloride for pharmaceutical and research applications, subject to applicable regulatory and quality requirements.
Fingolimod is primarily associated with pharmaceutical formulations used for relapsing forms of multiple sclerosis. Its active metabolite, fingolimod-phosphate, acts on sphingosine-1-phosphate receptors and contributes to its immunomodulatory activity.
Store Fingolimod Hydrochloride in a well-closed container, protected from unsuitable environmental conditions. Specific storage requirements should follow the applicable product specification, pharmacopoeial requirements and manufacturer-approved storage conditions.
Fingolimod Hydrochloride is described in the USP-NF. The USP definition specifies NLT 98.0% and NMT 102.0% of Fingolimod Hydrochloride on an anhydrous and solvent-free basis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms by IR / HPLC retention time / Chloride identification |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |