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1270480

USP

Fingolimod Hydrochloride

United States Pharmacopeia (USP) Reference Standard

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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:
Molecular Weight:
343.93

biological source

synthetic

agency

USP

API family

fingolimod

form

powder

manufacturer/tradename

USP

storage condition

protect from light

color

white

solubility

DMSO: soluble
ethyl acetate: soluble
water: soluble

application(s)

pharmaceutical

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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1 of 4

This Item
Y0002055PHR2790SML0700
USP

1270480

Fingolimod Hydrochloride

vibrant-m

Y0002055

Fingolimod hydrochloride

Supelco

PHR2790

Fingolimod Hydrochloride

FTY720 ≥98% (HPLC)

SML0700

FTY720

application(s)

pharmaceutical

application(s)

pharmaceutical

application(s)

-

application(s)

-

form

powder

form

powder

form

powder

form

powder

biological source

synthetic

biological source

synthetic

biological source

-

biological source

-

agency

USP

agency

EP

agency

traceable to Ph. Eur. Y0002055, traceable to USP 1270480

agency

-

API family

fingolimod

API family

fingolimod

API family

fingolimod

API family

-

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

Fingolimod Hydrochloride USP reference standard may be used to quantify the analyte in gel, capsule and other pharmaceutical formulations, active pharmaceutical ingredient (API) and pharmaceutical dosage forms by liquid chromatography (LC) based techniques.

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.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

pictograms

Health hazard

signalword

Warning

hcodes

Hazard Classifications

STOT RE 2

target_organs

Immune system

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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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)
Fingolimod Hydrochloride
Fingolimod Hydrochloride USP Monograph; USP42-NF37:United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(6)(1), 1849-1849 (2020)
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)
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)

Related Content

A rapid, accurate, and simple method was implemented for the total chromatographic purity analysis of Fingolimod Hydrochloride by High-Performance Liquid Chromatography equipped with a Diode Array Detector.

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