Description

Fingolimod Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of Fingolimod, an active pharmaceutical ingredient. This compound is critical for ensuring the purity, safety, and regulatory compliance of Fingolimod-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fingolimod Impurity 4 in Fingolimod API and finished dosage forms.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Employed as a system suitability and calibration standard in routine QC testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Research & Development: Utilized in process chemistry R&D to understand and minimize the formation of this impurity during the synthesis of Fingolimod.

Basic Information

Product Name	Fingolimod Impurity 4
CAS No.	177259-52-8
Molecular Formula	C19H33NO2
Molecular Weight	307.47 g/mol
Synonyms	(2S)-1-{[(2S,3S,4R)-3,4-Dihydroxy-1,1-diphenyl-3-(phosphonooxy)butan-2-yl]amino}-3-(octyloxy)propan-2-ol; Fingolimod Related Compound 4; FTY720 Impurity 4; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Impurity; Gilenya Impurity 4
EINECS	Contact for details

Quality Control

Our Fingolimod Impurity 4 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents, ensuring compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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