Description

Amorolfine Ep Impurity F is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antifungal agent Amorolfine. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical industry for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Amorolfine-related impurities during drug substance and drug product analysis.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring final product quality.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determinations.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Amorolfine Ep Impurity F
CAS No.	106614-66-8
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	(±)-cis-2,6-Dimethyl-4-[2-methyl-3-(4-tert-butylphenyl)propyl]morpholine; Amorolfine Related Compound F; Amorolfine Impurity F; 4-[2-Methyl-3-(4-tert-butylphenyl)propyl]-2,6-cis-dimethylmorpholine; Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-, cis-; Amorolfine EP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Amorolfine Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture.

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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