Description

Amorolfine Impurity C(Ep) is a high-purity chemical reference standard, specifically identified as an epimer of Amorolfine Impurity C. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality control laboratories, and API producers involved in the development and production of the antifungal agent Amorolfine HCl. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Amorolfine HCl active pharmaceutical ingredient (API) and related drug products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for the precise separation and detection of process-related impurities.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control impurity profiles, ensuring final drug product meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., FDA, EMA) by providing characterized impurity material for stability studies and impurity identification reports.
• Research & Development: Utilized in degradation studies and forced degradation experiments to understand the stability profile of Amorolfine and its degradation pathways.

Basic Information

Product Name	Amorolfine Impurity C(Ep)
CAS No.	732228-93-2
Molecular Formula	C₂₁H₃₅NO
Molecular Weight	317.51 g/mol
Synonyms	(±)-cis-2,6-Dimethyl-4-[2-methyl-3-(p-tert-pentylphenyl)propyl]morpholine; Amorolfine Related Compound C (Epimer); Amorolfine EP Impurity C; Amorolfine Impurity C (Diastereomer); (2R*,6S*)-2,6-Dimethyl-4-[2-methyl-3-(4-(1,1-dimethylpropyl)phenyl)propyl]morpholine; (2R*,6S*)-2,6-Dimethyl-4-[2-methyl-3-(p-tert-pentylphenyl)propyl]morpholine
EINECS	Contact for details

Quality Control

Every batch of Amorolfine Impurity C(Ep) is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitability for its intended use as a pharmaceutical reference standard.

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 under appropriate conditions to maintain stability.

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.