Description

Fingolimod Impurity C is a specified impurity and degradation product of the active pharmaceutical ingredient Fingolimod HCl, used in the treatment of multiple sclerosis. Its precise identification and quantification are critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. This reference standard is essential for pharmaceutical R&D and quality control laboratories involved in method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Fingolimod Impurity C in Fingolimod HCl drug substance and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability and quantitation standard in the routine QC testing of pharmaceutical raw materials and finished products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Fingolimod Impurity C
CAS No.	296282-46-7
Molecular Formula	C₁₉H₃₃NO₂
Molecular Weight	307.47 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; FTY720 Impurity C; (R)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Fingolimod EP Impurity C; Fingolimod Related Compound C; S1P Receptor Modulator Impurity; Gilenya Impurity C
EINECS	Contact for details

Quality Control

Every batch of Fingolimod Impurity C is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and analytical data is provided with each shipment.

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); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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