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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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100 TEST
CN¥1,938.30
500 TEST
CN¥6,857.34

About This Item

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

CN¥1,938.30


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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

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Show Differences

1 of 4

This Item
440159551635234893
density

1.045 g/mL at 25 °C (lit.)

density

1.045 g/mL at 25 °C (lit.)

density

0.975 g/mL at 25 °C (lit.)

density

0.917 g/mL at 25 °C (lit.)

Quality Level

100

Quality Level

200

Quality Level

200

Quality Level

200

bp

190 °C (lit.)

bp

190 °C (lit.)

bp

106 °C (lit.)

bp

118-119 °C (lit.)

refractive index

n20/D 1.431 (lit.)

refractive index

n20/D 1.431 (lit.)

refractive index

-

refractive index

n20/D 1.413 (lit.)

storage temp.

2-8°C

storage temp.

-

storage temp.

-

storage temp.

2-8°C

General description

Fingolimod Hydrochloride (fingolimod HCl), an S1P-receptor modulator, belongs to the class of synthetic glucocorticoid steroid drugs.[1][2][3][3]

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.
FTY720, an immunomodulating drug, acts as a sphingosine 1-phosphate (S1P) receptor modulator.

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

Signal Word

Warning

Hazard Statements

Precautionary Statements

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


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    Fingolimod Hydrochloride
    European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
    European pharmacopoeia, 4(1), 4989-4990 (2019)
    Sphingosine 1-phosphate receptor 1 as a useful target for treatment of multiple sclerosis
    Chiba K and Adachi K
    Pharmaceuticals (Basel, Switzerland), 5(5), 514-528 (2012)
    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)
    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)
    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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