Description

Itraconazole Desethylene-Seco-Piperazine Di-n-Formyl Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antifungal drug Itraconazole. This compound is critical for the accurate identification, quantification, and control of a specific process-related impurity, ensuring the final drug product meets stringent regulatory purity and safety standards. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Itraconazole and its related substances.
• Method Development & Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the level of this specific impurity during Itraconazole API synthesis and formulation.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Stability Studies: Employed as a marker to track impurity formation in stability-indicating studies of Itraconazole drug products.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Itraconazole Desethylene-Seco-Piperazine Di-n-Formyl Impurity
CAS No.	1199350-02-1
Molecular Formula	C30H34Cl2N6O5
Molecular Weight	621.53 g/mol
Synonyms	Itraconazole Desethylene Seco Piperazine Di-N-Formyl Impurity; Itraconazole Impurity 12; Itraconazole Related Compound 12; 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]-1-piperazinyl]phenyl]-2,4-dihydro-2-[(1-formyl-1-piperazinyl)methyl]-3H-1,2,4-triazol-3-one; (2R,4S)-rel-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-ylmethyl 4-[4-[4-[2,4-dihydro-2-[(1-formyl-1-piperazinyl)methyl]-3-oxo-5H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenyl ether
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including NMR, MS, and HPLC to ensure definitive identity and high purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data, supporting use in GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent moisture absorption.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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