Description

Fingolimod Ep Impurity D CAS NO 780729-32-0 is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound serves as a specified impurity for Fingolimod, a sphingosine 1-phosphate receptor modulator used in the treatment of multiple sclerosis. It is essential for researchers and quality assurance professionals in pharmaceutical development and manufacturing who require reliable standards to ensure product safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity is fundamental for conducting accurate impurity profiling and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fingolimod Ep Impurity D in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation and detection.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for impurity characterization reports required for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Fingolimod Ep Impurity D
CAS No.	780729-32-0
Molecular Formula	C19H33NO2
Molecular Weight	307.47 g/mol
Synonyms	(2S)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; (S)-2-Amino-2-[2-(4-n-octylphenyl)ethyl]-1,3-propanediol; Fingolimod EP Impurity D; Fingolimod Related Compound D; FTY720 EP Impurity D; FTY720 Related Compound D; S1P Receptor Modulator Impurity
EINECS	Contact for details

Quality Control

Every batch of Fingolimod Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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