Description

Posaconazole Impurity 43 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, qualification, and control of process-related impurities in the manufacturing of the antifungal drug Posaconazole. It is an essential material for analytical chemists and quality control professionals working in pharmaceutical development and regulatory compliance. The precise characterization of this impurity is vital for ensuring drug safety, efficacy, and meeting stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Impurity Profiling: Identification and quantification of Posaconazole-related substances in active pharmaceutical ingredient (API) batches.
• Quality Control & Assurance: Used in-house by API manufacturers and third-party testing labs to monitor and control impurity levels against ICH guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for FDA, EMA, and other health authority filings.
• Stability Studies: Employed as a marker to track impurity formation during drug product stability testing under various ICH conditions.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Posaconazole Impurity 43
CAS No.	357189-95-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 43; Posaconazole Impurity C; Posaconazole EP Impurity C; SCH 56592 Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[(3R,5R)-5-{(2S,3S)-2-hydroxy-3-[4-(1H-1,2,4-triazol-1-yl)phenyl]butan-2-yl}piperidin-1-yl]phenyl}-1,2,4-oxadiazol-3-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (IUPAC); Posaconazole Process Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 43 is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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