Description

Amorolfine Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality control of antifungal medications.

Application

• As a Pharmaceutical Reference Standard for the identification and quantification of impurities in Amorolfine API and finished drug products.
• For Analytical Method Development and Validation (HPLC, LC-MS) in quality control laboratories.
• In Stability Studies to monitor degradation pathways and establish shelf-life for antifungal formulations.
• For Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA and EMA.
• As a critical reagent in Research and Development of new antifungal agents and related chemical processes.
• Used in Pharmacopoeial Testing to verify compliance with monographs from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Amorolfine Impurity
CAS No.	67468-13-7
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; Amorolfine EP Impurity; Amorolfine USP Impurity; Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-, cis-; Loceryl Impurity
EINECS	Contact for details

Quality Control

Every batch of our Amorolfine Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification, assay, and impurity profiling via advanced chromatographic techniques (HPLC, GC) to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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