Description

Posaconazole Impurity 6 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 drug Posaconazole. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for maintaining the stringent purity profiles required in active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 6
CAS No.	2185472-85-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 6; Posaconazole Impurity F; Posaconazole EP Impurity F; Posaconazole USP Impurity; (2R,3S)-rel-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(4-{[(3R,5R)-5-{[(1H-1,2,4-Triazol-1-yl)carbonyl]methyl}-2,2-dimethyl-1,3-dioxan-3-yl]methoxy}phenyl)piperazin-1-yl]pentyl}-1,2,4-oxadiazol-3-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (IUPAC); UNII-Contact for details; Posaconazole Degradation Product; Posaconazole Process Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results and confirming compliance with relevant pharmacopeial standards (e.g., USP, EP). Our quality commitment ensures reliability for your most critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under appropriate conditions to prevent degradation or absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.