Description

Efinaconazole Impurity 32 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal active pharmaceutical ingredient, Efinaconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Efinaconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor and control impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Efinaconazole.

Basic Information

Item	Details
Product Name	Efinaconazole Impurity 32
CAS No.	2055038-63-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Efinaconazole Related Compound 32; Efinaconazole Specified Impurity 32; (2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (proposed); UNII-Contact for details; Efinaconazole EP Impurity G (Check); Efinaconazole USP Impurity; Potential Degradation Product of Efinaconazole
EINECS	Contact for details

Quality Control

Every batch of Efinaconazole Impurity 32 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH Q3 guidelines. A Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment, ensuring traceability and compliance for regulatory purposes.

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 tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified 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.