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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

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About This Item

Empirical Formula (Hill Notation):
C19H33NO2 · HCl
CAS Number:
162359-56-0
Molecular Weight:
343.93
UNSPSC Code:
41116107
NACRES:
NA.24

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

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Related Categories

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.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H373

Hazard Classifications

STOT RE 2

target_organs

Immune system

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

Lot/Batch Number

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A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects
Tanguay M, et al.
AAPS Open, 4(1), 3-3 (2018)
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Chim RB, et al.
Journal of Chemical and Engineering Data, 57(12), 3756-3760 (2012)

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