Description

Fingolimod Hydrochloride is a potent, orally active sphingosine 1-phosphate (S1P) receptor modulator. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacture of targeted immunomodulatory therapies. It is primarily utilized by pharmaceutical companies and research institutions engaged in the production of innovative treatments for multiple sclerosis and other autoimmune conditions.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral multiple sclerosis (MS) therapeutics.
• Clinical Research: Used in preclinical and clinical studies investigating novel applications in autoimmune and inflammatory diseases.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development and quality control in laboratories.
• Process Development: Key intermediate in the research and scale-up of synthetic routes for S1P receptor modulators.
• Formulation R&D: Employed in the development of various dosage forms, including tablets and capsules.

Basic Information

Product Name	Fingolimod Hydrochloride
CAS No.	162359-56-0
Molecular Formula	C19H33NO2•HCl
Molecular Weight	343.93 g/mol
Synonyms	FTY720 Hydrochloride; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Hydrochloride; Gilenya (Brand Name) API; Fingolimod HCl; (2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol hydrochloride); S1P Receptor Modulator FTY720 HCl; Immunosuppressant FTY720 Hydrochloride
EINECS	Contact for details

Quality Control

Our Fingolimod Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with your required standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Specific Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.