Description

Itraconazole Impurity 21 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal active pharmaceutical ingredient (API) Itraconazole. It serves as an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The precise characterization of this impurity is fundamental to maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Itraconazole API and finished drug products.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial limits (USP, EP, ICH).
• Stability Studies: Employed to monitor impurity profiles and degradation pathways in Itraconazole formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in academic and industrial R&D for studying the metabolism, synthesis pathways, and degradation chemistry of Itraconazole.

Basic Information

Product Name	Itraconazole Impurity 21
CAS No.	89848-20-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Itraconazole Related Compound 21; Itraconazole EP Impurity I; Itraconazole USP Impurity; Itraconazole Process Impurity; 4-[4-[4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-2-[(1S)-1-methylpropyl]-3H-1,2,4-triazol-3-one (IUPAC); Itraconazole Degradant; Itraconazole Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Itraconazole Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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