Fingolimod Related Compounds & Impurities

Fingolimod is a sphingosine-1-phosphate receptor modulator that sequesters lymphocytes in lymph nodes, used as the first oral disease-modifying therapy for relapsing multiple sclerosis.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Fingolimod reference standards, pharmacopeial and non-pharmacopeial Fingolimod impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Fingolimod-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Fingolimod Hydrochloride
Fingolimod Hydrochloride
Fingolimod
Fingolimod Phosphate
Fingolimod Palmitate Amide
Fingolimod Stearate Amide
N-Acetyl Deshydroxymethyl Fingolimod
Fingolimod Heptyl Impurity
Fingolimod Methyl Impurity
Fingolimod Impurity 8
Fingolimod Nitro Impurity
Fingolimod Acetyl Amide Impurity
Fingolimod Impurity 11
beta-Amino-4-octyl-Benzenebutanol Hydrochloride
ortho-Fingolimod
Fingolimod Dimer Impurity
2-Amino-2-[2-[4-(1-hydroxyoctyl)phenyl]ethyl]-1,3-propanediol
Fingolimod 4-Hydroxy Impurity
3-Formylbenzoic acid
Isophthalaldehyde
Fingolimod Hydrochloride EP Impurity I
N-Hydroxy Fingolimod
Fingolimod Hexyl Impurity
Fingolimod O-Acetyl Impurity
Fingolimod EP Impurity C
Heptyl Deoctyl Fingolimod Hydrochloride
Fingolimod EP Impurity F
Fingolimod EP Impurity E
2-Nitrodeamino Fingolimod
Fingolimod EP Impurity H
N-Methyl Fingolimod
N,N- Dimethyl Fingolimod
Fingolimod Decyl Impurity (hydrate Form)
Fingolimod EP Impurity A Hydrochloride
2-(4-Octylphenyl)-1-iodoethane
2-(4-Octylphenyl)ethyl 1-Methanesulfonate
Fingolimod Hydrochloride Impurity D
beta-Amino-4-octylbenzenebutanol Hydrochloride
Fingolimod N-Oxide
2-acetamido-2-(4-octanoylphenethyl)propane-1,3-diyldiacetate
Deshydroxymethyl Fingolimod
Fingolimod EP Impurity G
Fingolimod o-Bromo Intermediate
Fingolimod m-Bromo Intermediate
4-Octanoylstyrene
2-chloro-1-(4-octylphenyl)ethan-1-one
Fingolimod Hydrochloride Nitro Hydroxy Diol Impurity
Fingolimod Impurity 32
N-Ethyl Fingolimod
Fingolimod EP Impurity E Hydrochloride
Fingolimod EP Impurity F Hydrochloride
2-Amino-4-(4-octylphenyl)butanol
Fingolimod Impurity 30
Fingolimod Nonyl Impurity
Fingolimod Impurity 13
2-amino-2-(hydroxymethyl)-4-(4-octylphenyl)butanoic acid
1-(1-iodoethyl)-4-octylbenzene
Fingolimod Impurity 38
Fingolimod Impurity 22
Fingolimod Impurity 24
Fingolimod Impurity 2
2-Nitro-4-(4-octylphenyl)butan-1-ol
Fingolimod Impurity 25
Diethyl 2-acetamido-2-phenethylmalonate
N-[1,1-bis(hydroxymethyl)-3-phenylpropyl]- Acetamide
Fingolimod Impurity 42
Fingolimod Impurity 26
Fingolimod Impurity 44
Fingolimod Impurity 36
Fingolimod Impurity 47
Fingolimod Impurity 48
Fingolimod N,O-Diacetyl Impurity
Fingolimod Impurity 12
Fingolimod Impurity 49
Fingolimod Impurity 40
Fingolimod N-Nitroso Impurity
Fingolimod Impurity 5
Fingolimod impurity 1
Fingolimod N-Nitroso Impurity 2

Metabolites

1-[4-(3-Amino-4-hydroxy-3-hydroxymethyl-butyl)-phenyl]-octan-1-one

Isotope Labelled Compounds

Fingolimod-D4 Hydrochloride
Fingolimod D4
Fingolimod Phosphate D4