Description

Isavuconazole Impurity CAS NO 21661-87-0 is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity or intermediate in the synthesis and quality control of the antifungal API Isavuconazole. It is essential for analytical method development, validation, and ensuring regulatory compliance in drug manufacturing. Pharmaceutical companies, contract research organizations (CROs), and quality control laboratories require this standard to guarantee the safety, efficacy, and purity of their final drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Isavuconazole active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor process-related impurities and degradation products.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Process Chemistry Research: Used as an intermediate or marker to study and optimize the synthetic pathway of Isavuconazole, helping to minimize impurity formation.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to track impurity profiles in stability testing of drug substances and products under various ICH-prescribed conditions.

Basic Information

Product Name	Isavuconazole Impurity
CAS No.	21661-87-0
Molecular Formula	C22H17F2N5O2S
Molecular Weight	469.47 g/mol
Synonyms	Isavuconazole Related Compound; (2R,3R)-3-(4-(4-Cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; BAL4815 Impurity; Isavuconazonium Impurity; Isavuconazole Intermediate; (αR,βR)-α-(2,5-Difluorophenyl)-β-methyl-α-[4-(4-cyanophenyl)-2-thiazolyl]-1H-1,2,4-triazole-1-ethanol
EINECS	Contact for details

Quality Control

Our Isavuconazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory needs. The product is suitable for use as a reference standard in compliance with ICH Q3A(R2), Q3B(R2), and current pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The compound is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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