Description

Isavuconazole Impurity 1 is a designated reference standard used for the analytical profiling and quality control of the antifungal pharmaceutical agent, Isavuconazole. This high-purity compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by enabling the accurate identification and quantification of this specific impurity during manufacturing and stability testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams focused on developing and producing high-grade antifungal medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Method Development and Validation: Crucial for developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Isavuconazole API.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of Isavuconazole Impurity 1, ensuring final product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to identify and track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to understand impurity formation pathways.

Basic Information

Product Name	Isavuconazole Impurity 1
CAS No.	2169911-47-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3R)-2-(2,5-Difluorophenyl)-3-(4-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; Isavuconazole Related Compound; BAL4815 Impurity; Isavuconazole EP Impurity; Isavuconazole USP Impurity; Antifungal Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole Impurity 1 is manufactured and analyzed 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 for reference materials. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified.

Specification

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

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