Description

Efinaconazole Related 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 efficacy of the active pharmaceutical ingredient Efinaconazole, an antifungal medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Efinaconazole API and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish impurity profiles, retention times, and detection limits.
• Regulatory Compliance & Filings: Essential for preparing impurity identification and qualification reports required by agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity in Efinaconazole formulations under various storage conditions.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity.
• Pharmacopoeial Testing: Applied as a system suitability and identification standard in tests per USP, EP, or other pharmacopeias.

Basic Information

Product Name	Efinaconazole Related Impurity 13
CAS No.	2055912-03-1
Molecular Formula	C18H22F2N4O2
Molecular Weight	364.39 g/mol
Synonyms	Efinaconazole Impurity 13; (2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; Efinaconazole EP Impurity G; Efinaconazole USP Related Compound; (2R,3R)-3-(4-Methylenepiperidino)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; Jublia Impurity; KP-103 Impurity
EINECS	Contact for details

Quality Control

Every batch of Efinaconazole Related Impurity 13 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant regulatory requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The material is hygroscopic (moisture-sensitive) and should be handled 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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