Description

Fingolimod C9 Homolog (Hcl Salt) is a high-purity chemical reference standard and synthetic intermediate of significant interest in pharmaceutical research and development. This compound is structurally related to Fingolimod (FTY720), a sphingosine-1-phosphate receptor modulator, making it a critical tool for metabolic studies, impurity profiling, and analytical method development. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development and quality control of complex active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of related substances in Fingolimod API and finished drug products.
• Process Impurity Profiling: Serves as a key marker for monitoring and controlling homolog-related impurities during the synthesis and purification of Fingolimod.
• Metabolic and Pharmacokinetic Studies: Employed in research to understand the metabolic pathways, distribution, and excretion profiles of Fingolimod analogs.
• Analytical Method Development & Validation: A critical component for developing, calibrating, and validating sensitive HPLC, LC-MS, and other chromatographic methods.
• Chemical Synthesis Intermediate: Acts as a building block or precursor in the research-scale synthesis of novel sphingosine-1-phosphate receptor-targeting compounds.
• Quality Control & Assurance (QC/QA): Essential for ensuring batch-to-batch consistency and compliance with stringent regulatory specifications in API manufacturing.

Basic Information

Product Name	Fingolimod C9 Homolog (Hcl Salt)
CAS No.	296282-40-1
Molecular Formula	C20H38ClNO2
Molecular Weight	359.98 g/mol
Synonyms	2-Amino-2-[2-(4-nonylphenyl)ethyl]propane-1,3-diol hydrochloride; FTY720 C9 Homolog Hydrochloride; 2-(4-Nonylbenzyl)propane-1,3-diol, 2-amino-, hydrochloride; (2R)-2-Amino-2-[2-(4-nonylphenyl)ethyl]propane-1,3-diol hydrochloride; S1P Receptor Modulator C9 Homolog HCl; Fingolimod C9 Analog HCl Salt; 2-Amino-2-(2-(4-nonylphenyl)ethyl)-1,3-propanediol hydrochloride
EINECS	Contact for details

Quality Control

Our Fingolimod C9 Homolog (Hcl Salt) is manufactured under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents and moisture content. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with specified purity criteria, typically ≥95% to ≥98% (HPLC).

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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