Description

Posaconazole Diastereoisomer 11 is a specific stereoisomeric impurity of the broad-spectrum triazole antifungal agent, Posaconazole. This compound is of critical importance in pharmaceutical research and development for ensuring drug purity, safety, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a reference standard in quality control testing, method development, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Posaconazole Diastereoisomer 11 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating precise analytical methods, such as HPLC and UPLC, to monitor this specific impurity.
• Quality Control & Assurance: Critical for in-process testing and release testing of Posaconazole API to ensure compliance with pharmacopeial limits (e.g., USP, EP) for specified impurities.
• Stability Studies: Employed to track the formation of this diastereoisomer over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the behavior of this stereoisomer.

Basic Information

Item	Detail
Product Name	Posaconazole Diastereoisomer 11
CAS No.	171228-50-5
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Impurity 11; Posaconazole Diastereomer 11; (2R,3S,4R,5R)-5-{5-(2,4-Difluorophenyl)-5-[(1S,2S)-1-ethyl-2-hydroxypropyl]-4-{4-[4-(4-{[(3R,5R)-5-{2H-1,2,3-triazol-2-ylmethyl}tetrahydro-2H-pyran-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4H-1,2,4-triazol-3-yl}tetrahydro-2H-pyran-2,3,4-triol; SCH 56592 Diastereoisomer 11; Noxafil Impurity 11
EINECS	Contact for details

Quality Control

Our Posaconazole Diastereoisomer 11 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (NMR, IR, MS), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra where applicable, is provided with every shipment to ensure full traceability and compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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