Description

Amorolfine Impurity 5 (Amorolfine Ep Impurity E) is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for quality control and analytical method validation during the production of the antifungal drug Amorolfine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams to ensure drug safety and efficacy by accurately identifying and quantifying process-related impurities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods (HPLC, LC-MS).
• Drug Substance Impurity Profiling: Used in the identification, qualification, and control of impurities in Amorolfine Active Pharmaceutical Ingredient (API) batches.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor and ensure impurity levels remain within specified limits (ICH guidelines).
• Research & Development: Used in stability studies and forced degradation studies to understand the degradation pathways of Amorolfine.
• Method Development & Transfer: Aids in developing and transferring robust analytical methods between R&D, QC, and manufacturing sites.

Basic Information

Product Name	Amorolfine Impurity 5 (Amorolfine Ep Impurity E)
CAS No.	2134097-34-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amorolfine EP Impurity E; Amorolfine Related Compound E; Amorolfine Impurity E; (2R,6S)-rel-2,6-Dimethyl-4-[2-methyl-3-(4-tert-butylphenyl)propyl]morpholine; Amorolfine Isomer; Amorolfine Process Impurity; Amorolfine Degradant
EINECS	Contact for details

Quality Control

Every batch of Amorolfine Impurity 5 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing using advanced chromatographic techniques to ensure identity, purity, and consistency. Comprehensive Certificates of Analysis (COA) are provided, detailing purity by HPLC, related substances, and other critical parameters in compliance with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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