Description

Posaconazole Impurity 44 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antifungal drug Posaconazole. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a known impurity for identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Posaconazole batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate control over the manufacturing process.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Posaconazole Impurity 44
CAS No.	357189-97-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 44; Posaconazole EP Impurity 44; Posaconazole USP Impurity 44; Posaconazole Process Impurity; 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2-dihydro-2-[(S)-1-methylpropyl]-3H-1,2,4-triazol-3-one (IUPAC); SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 44 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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