Description

Posaconazole Impurity 57 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) Posaconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Posaconazole API and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and characterize Posaconazole Impurity 57 during stability studies and forced degradation studies.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require complete impurity identification and qualification data.
• Research & Development: Employed in pharmaceutical R&D to study the degradation pathways, metabolism, and pharmacokinetics of Posaconazole.
• Quality Assurance/Quality Control (QA/QC): Used as a system suitability standard and for routine batch analysis to ensure product purity and consistency.

Basic Information

Product Name	Posaconazole Impurity 57
CAS No.	195735-34-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 57; Posaconazole EP Impurity G; Posaconazole USP Impurity; 4-[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-dihydro-2-[(S)-1-methylpropyl]-3H-1,2,4-triazol-3-one; UNII-7J1QWH6N0F; SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 57 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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