Description

Posaconazole Impurity 47 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 required 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 highest standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during drug synthesis and stability studies.
• 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 Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 47
CAS No.	1388148-29-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 47; Posaconazole EP Impurity G; Posaconazole USP Impurity; SCH 56592 Impurity 47; 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one; UNII-9I6U8W6A8K
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 47 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

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 dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator or under an inert atmosphere after opening.

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%
Water Content (KF)	≤ 5.0% w/w
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.