Description

Isavuconazole Impurity 11 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal API Isavuconazole. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of high-grade antifungal medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Isavuconazole active pharmaceutical ingredient (API).
• Method Development & Validation: Essential for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in quality control laboratories.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Isavuconazole to minimize impurity formation.
• Quality Assurance/Quality Control (QA/QC): Employed as a system suitability component and for routine batch release testing to ensure API meets stringent purity specifications.

Basic Information

Product Name	Isavuconazole Impurity 11
CAS No.	2732924-99-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isavuconazole Related Compound 11; Isavuconazole Impurity; BAL4815 Impurity 11; (2R,3R)-2-(2,5-Difluorophenyl)-3-(4-{[(3R,5R)-5-{2-(1H-1,2,4-triazol-1-yl)ethyl}-1-(1,2,4-thiadiazol-3-yl)piperidin-3-yl]oxy}phenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (Isomer); Isavuconazonium Impurity; Antifungal Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.