Description

Fingolimod o-Acetyl Impurity is a specified, high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fingolimod. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of a key process-related impurity. It is an essential tool for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry, particularly those involved in the development, manufacturing, and regulatory compliance of sphingosine 1-phosphate receptor modulator drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the o-Acetyl impurity in Fingolimod HCl API and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine batch release testing and in-process control (IPC) to monitor impurity levels and ensure API purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various stress conditions (thermal, humidity, photolytic).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis routes to minimize its presence.

Basic Information

Product Name	Fingolimod o-Acetyl Impurity
CAS No.	1807973-92-7
Molecular Formula	C23H35NO3
Molecular Weight	373.53 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol 1,3-Diacetate; FTY720 o-Acetyl Impurity; (2R)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol 1,3-diacetate; Gilenya o-Acetyl Related Compound; Fingolimod Diacetate Impurity; 1,3-Diacetyl Fingolimod; 2-(4-Octylphenethyl)-2-aminopropane-1,3-diol Diacetate
EINECS	Contact for details

Quality Control

Our Fingolimod o-Acetyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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