Description

Amorolfine Ep Impurity C is a high-purity chemical reference standard specifically identified as a process-related impurity of Amorolfine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in the synthesis and quality assurance of antifungal APIs. Ensuring the integrity and traceability of such impurities is fundamental to meeting stringent regulatory requirements for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Amorolfine active pharmaceutical ingredient (API).
• Analytical Method Development: Used in developing and validating HPLC, UPLC, or GC methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor and control impurity levels.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Research & Development: Employed in synthetic chemistry R&D to study degradation pathways and optimize purification processes.
• Pharmacopoeial Testing: Used as a system suitability component in testing to comply with pharmacopoeial monographs (e.g., EP, USP).

Basic Information

Product Name	Amorolfine Ep Impurity C
CAS No.	922734-43-8
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 C; Amorolfine Impurity C; Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-, cis-; Amorolfine EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Amorolfine Ep Impurity C 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 pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere 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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.