Description

Posaconazole Impurity 51 is a designated impurity of the antifungal API Posaconazole. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Posaconazole drug substances and products.

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 dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and detect process-related impurities.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products in Posaconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification stages of Posaconazole manufacturing.

Basic Information

Product Name	Posaconazole Impurity 51
CAS No.	357189-94-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 51; Posaconazole Impurity K; Posaconazole EP Impurity K; Posaconazole USP Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[(3R,5R)-5-{(2S,3S)-2-hydroxy-3-pentyl}-3-(1H-1,2,4-triazol-1-ylmethyl)tetrahydrofuran-2-yl}phenyl)-4H-1,2,4-triazol-3-yl)-1,1,1-trifluorobutan-2-ol (Posaconazole isomer); UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 51 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, ensuring compliance with current pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (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 corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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