Description

Fingolimod Hexyl Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Fingolimod, a sphingosine 1-phosphate receptor modulator. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Fingolimod API and its formulations.
• Quality Control & Assurance: Used in routine HPLC/LC-MS analysis to monitor and control the levels of this specific impurity in drug substance and drug product batches to meet ICH guidelines.
• Stability Studies: Employed as a marker to track impurity profiles and degradation pathways in forced degradation and long-term stability programs.
• Regulatory Compliance: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process of Fingolimod.

Basic Information

Product Name	Fingolimod Hexyl Impurity
CAS No.	1201794-93-5
Molecular Formula	C23H41NO2
Molecular Weight	363.58 g/mol
Synonyms	2-Amino-2-[2-(4-hexylphenyl)ethyl]propane-1,3-diol; Fingolimod Hexyl Analog; Fingolimod EP Impurity H; Fingolimod Related Compound H; FTY720 Hexyl Impurity; (2-Amino-2-{2-[4-(hexyl)phenyl]ethyl}propane-1,3-diol); 2-Amino-2-(2-(4-hexylphenyl)ethyl)propane-1,3-diol
EINECS	Contact for details

Quality Control

Every batch of Fingolimod Hexyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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