Description

Posaconazole Impurity 43 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal drug Posaconazole by serving as a key marker for impurity profiling and method validation. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in drug development and manufacturing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Posaconazole active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and to ensure drug substance purity meets stringent pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Essential for preparing impurity data packages required for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Posaconazole.

Basic Information

Item	Details
Product Name	Posaconazole Impurity 43
CAS No.	1428118-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 43; Posaconazole EP Impurity C; Posaconazole USP Impurity; 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one; UNII-9I0K3J36U2
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 43 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. Comprehensive characterization is performed using advanced techniques like NMR, MS, and HPLC. Certificates of Analysis (COA) detailing purity, identity, and impurity data are available upon request.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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