Y0002055

Fingolimod hydrochloride

European Pharmacopoeia (EP) Reference Standard

• Synonym(s): FTY720, 2-Amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol hydrochloride, Fingolimod hydrochloride
• Empirical Formula (Hill Notation): C₁₉H₃₃NO₂ · HCl
• CAS Number: 162359-56-0
• Molecular Weight: 343.93
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• biological source: synthetic
• grade: pharmaceutical primary standard
• Agency: EP
• API family: fingolimod
• form: powder
• packaging: pkg of 110 mg
• manufacturer/tradename: EDQM
• storage condition: protect from light
• solubility: water: 100-1000 g/L
• application(s): pharmaceutical
• format: neat
• shipped in: ambient
• storage temp.: 2-8°C
• InChI: 1S/C19H33NO2.ClH/c1-2-3-4-5-6-7-8-17-9-11-18(12-10-17)13-14-19(20,15-21)16-22;/h9-12,21-22H,2-8,13-16,20H2,1H3;1H
• InChI key: SWZTYAVBMYWFGS-UHFFFAOYSA-N

Description

General description

Fingolimod Hydrochloride (fingolimod HCl), an S1P-receptor modulator, belongs to the class of synthetic glucocorticoid steroid drugs.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets, have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

This European Pharmacopoeia reference standard is intended for use only as specifically prescribed in the European Pharmacopoeia.

Biochem/physiol Actions

FTY720 is an immunomodulating drug and sphingosine 1-phosphate (S1P) receptor modulator. Phosphorylation of FTY270 by sphingosine kinase causes S1P1R internalization, which sequesters lymphocytes in lymph nodes, preventing them from taking part in an autoimmune response. Clinically, it has been approved for the treatment of multiple sclerosis (MS). It has also been shown to block and reverse paclitaxel-induced chemotherapy induced peripheral neuropathy (CIPN) through S1PR inhibition as well as inhibit the activity of histone deacetylases in the hippocampus of mouse brains, thereby modulating memory.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H373
• Precautionary Statements: P260 - P314 - P501
• Hazard Classifications: STOT RE 2
• Target Organs: Immune system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable