Description

Amorolfine Ep Impurity O is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antifungal agent Amorolfine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily utilized by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Amorolfine to ensure final product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Amorolfine Ep Impurity O in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine testing in pharmaceutical QC labs to monitor and control impurity levels during Amorolfine production, ensuring compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions to determine product shelf-life.
• Research & Development: Used in chemical and pharmacological research to study the degradation pathways and metabolism of Amorolfine.

Basic Information

Product Name	Amorolfine Ep Impurity O
CAS No.	73414-18-3
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	(2R,6S)-rel-2,6-Dimethyl-4-[2-methyl-3-(4-tert-butylphenyl)propyl]morpholine; Amorolfine Related Compound O; Amorolfine Impurity O; (rel)-cis-2,6-Dimethyl-4-[2-methyl-3-(p-tert-butylphenyl)propyl]morpholine; Amorolfine EP Impurity O
EINECS	Contact for details

Quality Control

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

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.