Description

Isavuconazole Impurity 24 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal API Isavuconazole. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark for identification and quantification during testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Used in the identification and quantification of impurities in Isavuconazole active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Compliance & Documentation: Essential for preparing impurity profiles and regulatory submission dossiers for agencies like the FDA and EMA.
• Method Development & Validation: Aids analytical chemists in developing and validating specific HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various storage conditions.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Isavuconazole Impurity 24
CAS No.	1176988-44-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isavuconazole Related Compound 24; Isavuconazole Impurity D; Isavuconazole EP Impurity D; Isavuconazole USP Impurity; (2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (proposed); BAL4815 Impurity; Cresemba Impurity
EINECS	Contact for details

Quality Control

Our Isavuconazole Impurity 24 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) providing detailed results from advanced analytical techniques such as HPLC, LC-MS, and NMR. We adhere to relevant industry standards to support our clients' regulatory and compliance needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
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.