Description

Isavuconazole Impurity CAS NO 338990-63-9 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antifungal drug Isavuconazole. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Isavuconazole.
• Impurity Profiling: Used in HPLC, LC-MS, and other chromatographic methods to identify, characterize, and control related substances in Isavuconazole API and finished drug products.
• Method Development and Validation: Critical for developing and validating analytical methods to meet ICH Q2(R1), USP, and other pharmacopeial guidelines.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure batch-to-batch consistency and compliance with specified impurity limits.

Basic Information

Product Name	Isavuconazole Impurity
CAS No.	338990-63-9
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 Drug Impurity; (2R,3R)-3-(4-Fluorophenyl)-2-(2,5-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole Impurity (CAS 338990-63-9) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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