Description

Posaconazole Impurity 49 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 by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and contract research organizations (CROs) engaged in the development and manufacturing of Posaconazole and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Posaconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control the level of this specific impurity, ensuring drug product specifications are met.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Posaconazole.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Synthesis: Serves as an intermediate or building block in chemical synthesis research for novel antifungal compounds or for studying structure-activity relationships (SAR).

Basic Information

Product Name	Posaconazole Impurity 49
CAS No.	1902954-05-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 49; Posaconazole Impurity; Posaconazole EP Impurity 49; Posaconazole USP Impurity 49; (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; UNII-9F8W6V5K0N; 1902954-05-5; Posaconazole Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 49 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The container should be kept in a well-ventilated area and handled according to standard laboratory safety practices for chemicals.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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