Description

Posaconazole Impurity CAS NO 1356330-68-1 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards and supporting robust pharmaceutical development.

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 drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles during drug synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Posaconazole meets the purity specifications outlined in pharmacopeias (USP, EP, JP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Stability Studies: Used to track the formation and levels of this specific impurity over time under various storage conditions, ensuring drug product shelf-life.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for minimal impurity generation.

Basic Information

Product Name	Posaconazole Impurity
CAS No.	1356330-68-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound; Posaconazole Process Impurity; Posaconazole Degradant; SCH 56592 Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(4-{[(3R,5R)-5-({2H-1,2,3-triazol-2-ylmethyl})methyl]oxy}phenyl)piperazin-1-yl]phenyl}-1,2,4-oxadiazol-3-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; 4-[4-[4-[[(3R,5R)-5-(2H-1,2,3-Triazol-2-ylmethyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]benzonitrile Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture absorption and contamination.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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