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Key Documents

Y0002055

Fingolimod hydrochloride

European Pharmacopoeia (EP) Reference Standard

Synonyme(s) :

FTY720, 2-Amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol hydrochloride, Fingolimod hydrochloride

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About This Item

Formule empirique (notation de Hill):
C19H33NO2 · HCl
Numéro CAS:
Poids moléculaire :
343.93
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Source biologique

synthetic

Qualité

pharmaceutical primary standard

Agence

EP

Famille d'API

fingolimod

Forme

powder

Conditionnement

pkg of 110 mg

Fabricant/nom de marque

EDQM

Conditions de stockage

protect from light

Solubilité

water: 100-1000 g/L

Application(s)

pharmaceutical

Format

neat

Conditions d'expédition

ambient

Température de stockage

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

Clé InChI

SWZTYAVBMYWFGS-UHFFFAOYSA-N

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Description générale

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.

Actions biochimiques/physiologiques

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.

Conditionnement

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

Autres remarques

Sales restrictions may apply.

Pictogrammes

Health hazard

Mention d'avertissement

Warning

Mentions de danger

Conseils de prudence

Classification des risques

STOT RE 2

Organes cibles

Immune system

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Fingolimod Hydrochloride
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 4(1), 4989-4990 (2019)
Rapid determination of fingolimod hydrochloride-related Substances and degradation products in API and pharmaceutical dosage forms by use of a stability-indicating UPLC method
Rajan N and Basha KA
Chromatographia, 77(21-22), 1545-1552 (2014)
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)
Solubility of dexamethasone in supercritical carbon dioxide
Chim RB, et al.
Journal of Chemical and Engineering Data, 57(12), 3756-3760 (2012)
Fingolimod hydrochloride gel for dermatological applications: optimization of formulation strength and effect of colloidal oatmeal (Aveeno?) as penetration enhancer
Tamakuwala M and Stagni G
Aaps Pharmscitech, 17(4), 907-914 (2016)

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