Description

Isavuconazole Impurity 2 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 antifungal active pharmaceutical ingredient, Isavuconazole. 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 maintaining the stringent purity profiles demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Isavuconazole API and its formulations.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, response factors, and detection limits for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to monitor the formation and level of this specific impurity in Isavuconazole drug substances and products under various storage conditions.
• Research & Development: Utilized in synthetic chemistry research to study the degradation pathways and formation mechanisms of Isavuconazole.
• Pharmacopoeial Testing: Applied as a system suitability and identification standard in testing protocols aligned with USP, EP, or other pharmacopoeias.

Basic Information

Item	Detail
Product Name	Isavuconazole Impurity 2
CAS No.	2001051-99-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isavuconazole Related Compound 2; Isavuconazole Impurity B; Isavuconazole Specified Impurity; BAL-4815 Impurity 2; (2R,3R)-2-(2,5-Difluorophenyl)-3-(4-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (Isavuconazole isomer/degradant); UNII-Contact for details; Azole Antifungal Impurity
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity criteria.

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 absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.