Description

Posaconazole Diastereoisomer 2 is a specific stereoisomeric form of the broad-spectrum triazole antifungal agent, posaconazole. This high-purity reference standard is critical for analytical research, method development, and quality control processes in pharmaceutical development. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in the synthesis, purification, and regulatory compliance of antifungal APIs and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification and quantification of the diastereoisomer 2 impurity in posaconazole active pharmaceutical ingredient (API) and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC, LC-MS) for stereoisomeric separation and impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for establishing specification limits and conducting routine batch testing to ensure the stereochemical purity of posaconazole meets pharmacopeial standards (USP, EP).
• Process Chemistry Research: Employed in studying and optimizing synthetic pathways to minimize the formation of this specific diastereoisomer during API manufacturing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over potential impurities as per ICH Q3A and Q3B guidelines.

Basic Information

Product Name	Posaconazole Diastereoisomer 2
CAS No.	213381-05-6
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Diastereomer 2; Posaconazole Stereoisomer 2; (2R,3S,4R,5R)-5-{5-(2,4-Difluorophenyl)-5-[(1S,2S)-1-ethyl-2-hydroxypropyl]-4-{4-(4-{4-[(3R,5R)-5-{2R,3S,4R,5R)-3,4-dihydroxy-5-{5-(2,4-difluorophenyl)tetrahydro-2-furanyl]-4-methyl-1-piperazinyl]phenyl}-1-piperazinyl}phenyl}-1H-1,2,4-triazol-1-ylmethyl}tetrahydro-2-furanyl}methanol; SCH 56592 Diastereoisomer 2; Noxafil Diastereoisomer 2
EINECS	Contact for details

Quality Control

Our Posaconazole Diastereoisomer 2 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to meet the requirements of your quality system.

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; prolonged exposure to light should be avoided.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Posaconazole Diastereoisomer 1	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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