Description

Posaconazole Impurity 60 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 reliable identification and quantification of this impurity are essential for maintaining drug purity standards.

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, 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 Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Posaconazole to understand impurity formation pathways.
• 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.
• Research & Development: Used in pharmaceutical R&D to study the metabolism, synthesis pathways, and degradation chemistry of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 60
CAS No.	2134652-05-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 60; Posaconazole EP Impurity 60; Posaconazole USP Impurity 60; Posaconazole Process Impurity 60; Posaconazole Degradant 60; (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
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 60 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. Comprehensive characterization is performed using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) are available upon request, providing detailed information on purity, identity, and impurity profile.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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