Description

Efinaconazole Impurity 13 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in antifungal drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Efinaconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and investigational new drug applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for the main API.
• Quality Assurance/Control (QA/QC): Serves as a system suitability standard and for routine batch analysis in pharmaceutical QA/QC laboratories.

Basic Information

Product Name	Efinaconazole Impurity 13
CAS No.	2055038-61-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3S)-2-(2,4-Difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; Efinaconazole Related Compound 13; Efinaconazole EP Impurity I; Efinaconazole USP Impurity; Jublia Impurity; KP-103 Impurity
EINECS	Contact for details

Quality Control

Every batch of Efinaconazole Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced spectroscopic and chromatographic techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request, supporting cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. Keep the container tightly sealed when not in use.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.