Description

Posaconazole Impurity CAS NO 1229428-89-0 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal drug Posaconazole by serving as a benchmark in impurity profiling and method validation. It is primarily needed by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in drug development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Posaconazole active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine quality control testing to monitor batch-to-batch consistency and ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this impurity under various conditions.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and synthesis of Posaconazole and related compounds.

Basic Information

Product Name	Posaconazole Impurity
CAS No.	1229428-89-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound; Posaconazole Specified Impurity; Posaconazole Process Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(4-{[(3R,5R)-5-(2,4-Difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-1,2,4-oxadiazol-3-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol (IUPAC); UNII-Contact for details; Posaconazole Impurity Standard; Posaconazole Reference Standard
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity content.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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