Description

Amorolfine Ep Impurity A CAS NO 78613-39-5 is a high-purity chemical reference standard, specifically identified as a key impurity of the antifungal agent Amorolfine. This compound is critical for pharmaceutical research and development, serving as an essential benchmark for analytical method validation and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Amorolfine-based drug products.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of Amorolfine-related impurities in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of degradation products in Amorolfine drug substances and products under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and metabolic pathways of Amorolfine.

Basic Information

Product Name	Amorolfine Ep Impurity A
CAS No.	78613-39-5
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	(±)-cis-2,6-Dimethyl-4-[2-methyl-3-(p-tert-butylphenyl)propyl]morpholine; Amorolfine Related Compound A; Amorolfine Impurity A; Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-, cis-; cis-4-[2-Methyl-3-[4-(tert-butyl)phenyl]propyl]-2,6-dimethylmorpholine
EINECS	Contact for details

Quality Control

Every batch of Amorolfine Ep Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B and pharmacopeial (EP/USP) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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