Description

Fingolimod Impurity 43 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fingolimod. This compound is critical for ensuring the purity, safety, and efficacy of Fingolimod-based drug products by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of this important immunomodulatory therapy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fingolimod Impurity 43 in Fingolimod API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., ANDA, NDA, CTA) to support impurity identification and control strategies.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Fingolimod.

Basic Information

Product Name	Fingolimod Impurity 43
CAS No.	1027850-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fingolimod Related Compound 43; Fingolimod EP Impurity 43; Fingolimod USP Impurity 43; FTY720 Impurity 43; (2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol) Impurity; Gilenya Impurity 43; Sphingosine 1-Phosphate Receptor Modulator Impurity
EINECS	Contact for details

Quality Control

Our Fingolimod Impurity 43 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant specifications. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.