Description

Efinaconazole Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Efinaconazole, an antifungal medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Efinaconazole API and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Quality Control and Assurance (QC/QA) as a certified reference material for batch release testing.
• Stability Studies to monitor and quantify degradation products under various storage conditions.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development (R&D) of new synthetic pathways and purification processes for Efinaconazole.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Efinaconazole Impurity 12
CAS No.	2055038-60-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(13R,14S)-13-Methyl-14-(4-(4-(pentan-3-yl)phenoxy)phenyl)-1-oxa-4,10-diazacyclopentadeca-10,12,14-trien-5-one; Efinaconazole Related Compound 12; Efinaconazole EP Impurity J; Efinaconazole USP Impurity; Efinaconazole Process Impurity; Antifungal Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Efinaconazole Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines for impurities. Comprehensive characterization is performed using advanced techniques like NMR, MS, and HPLC. Certificates of Analysis (COA) with detailed chromatographic purity, batch-specific data, and traceability are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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