Description

Posaconazole Diastereoisomer 12 is a specific stereoisomeric form of the broad-spectrum triazole antifungal agent, posaconazole. This high-purity reference standard is critical for pharmaceutical research and development, particularly in the analysis, method validation, and quality control of posaconazole-based drug substances and products. It is an essential material for analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories who require definitive standards to ensure product purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the qualitative and quantitative analysis of posaconazole in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for the separation and detection of posaconazole and its related substances.
• Impurity Profiling and Identification: Essential for identifying, characterizing, and quantifying process-related impurities and degradation products in posaconazole manufacturing.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive data on product composition and impurity levels.
• Stability Studies: Employed as a benchmark in forced degradation and long-term stability studies to monitor the integrity of posaconazole formulations.
• Pharmacokinetic & Metabolite Research: Acts as a starting point or comparator in studies investigating the metabolism and pharmacokinetic profile of posaconazole.

Basic Information

Product Name	Posaconazole Diastereoisomer 12
CAS No.	213381-04-5
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Diastereomer 12; Posaconazole Related Compound 12; (2R,3S,4R,5R)-5-{5-(4-(4-{4-[4-(4-{[(3R,5R)-5-{(2S,3S,4R,5S)-5-[4-(4-Cyanophenyl)-1H-1,2,3-triazol-1-yl]-3,4-dihydroxytetrahydro-2-furyl]methyl}-2-oxo-1,3-dioxolan-4-yl)methoxy]phenyl}-1-piperazinyl)phenyl}-1H-1,2,4-triazol-1-yl)methyl]-2,2-dimethyltetrahydro-3,4-furandiol; SCH 56592 Diastereoisomer 12; Noxafil Diastereoisomer 12
EINECS	Contact for details

Quality Control

Our Posaconazole Diastereoisomer 12 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity, and related substances is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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 individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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