Description

Posaconazole Diastereoisomer 13 is a high-purity chemical reference standard, specifically one of the stereoisomers of the broad-spectrum antifungal agent Posaconazole. This compound is critical for analytical research and development, serving as a key marker for the identification, quantification, and impurity profiling of Posaconazole in pharmaceutical formulations. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and manufacture of antifungal medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling and Control: Essential for identifying and quantifying this specific diastereomeric impurity in Posaconazole Active Pharmaceutical Ingredient (API) and finished drug products to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Method Development and Validation: Serves as a critical component in developing and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Pharmacokinetic and Metabolic Studies: Utilized in research to understand the stereoselective metabolism, distribution, and excretion of Posaconazole isomers.
• Quality Assurance & Control (QA/QC): Employed in routine batch release testing to confirm the identity and purity of Posaconazole, supporting cGMP compliance.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Posaconazole Diastereoisomer 13
CAS No.	1229428-90-3
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Diastereomer 13; Posaconazole Stereoisomer 13; (2R,3S,4R,5R)-5-(2,4-Difluorophenyl)-5-[(1S,2S)-1-ethyl-2-hydroxypropyl]-3-[(1H-1,2,4-triazol-1-yl)methyl]-4-[(2S,3S)-2-hydroxypentan-3-yl]oxolan-2-one; SCH 56592 Diastereoisomer; Noxafil Diastereoisomer; UNII-6TK1G07BHT (specific isomer); Antifungal Triazole Derivative Diastereomer.
EINECS	Contact for details

Quality Control

Our Posaconazole Diastereoisomer 13 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), stereochemical identity confirmation (NMR, Optical Rotation), and residual solvent analysis (GC) to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a desiccated environment. For long-term storage, consider conditions under an inert atmosphere.

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%
Diastereomeric Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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