Description

Isavuconazole Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient, Isavuconazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying process-related impurities during drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Isavuconazole Impurity 1 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods, including HPLC, UPLC, and LC-MS, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC testing of Isavuconazole API and formulations to monitor impurity levels and ensure they remain within specified safety limits.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and eliminate the source of this specific impurity.

Basic Information

Item	Details
Product Name	Isavuconazole Impurity 1
CAS No.	2069200-13-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isavuconazole Related Compound 1; Isavuconazole Impurity A; Isavuconazole EP Impurity A; Isavuconazole USP Impurity; BAL4815 Impurity 1; (2R,3R)-2-(2,5-Difluorophenyl)-3-(4-{[(3R,5R)-5-{2-(1H-1,2,4-triazol-1-yl)acetyl}piperidin-3-yl]oxy}phenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality standards are designed to meet the requirements for use as a reference standard in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be sealed tightly after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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