Description

Gilenia is a high-purity pharmaceutical active ingredient, also known by its CAS number 162359-55-9. This compound is a critical intermediate or active pharmaceutical ingredient (API) valued for its specific biological activity and structural role in advanced therapeutic formulations. It is essential for manufacturers in the pharmaceutical and biotechnology sectors requiring reliable, high-quality raw materials for research, development, and commercial production.

Application

• Pharmaceutical API Synthesis: Primary use as a key intermediate or active ingredient in the manufacture of prescription medications.
• Biomedical Research: Utilized in preclinical and clinical research studies to investigate therapeutic mechanisms and efficacy.
• Process Development: Serves as a standard or starting material for scaling up and optimizing synthetic routes in process chemistry.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control testing.
• Formulation Development: Incorporated into the development of various dosage forms, including tablets, capsules, and injectables.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished drug products.

Basic Information

Product Name	Gilenia
CAS No.	162359-55-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fingolimod; FTY720; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Gilenya (brand name); Fingolimod hydrochloride; Sphingosine 1-phosphate receptor modulator
EINECS	Contact for details

Quality Control

Our Gilenia (CAS 162359-55-9) is produced and tested 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 and current Good Manufacturing Practices (cGMP). A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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