Description

Posaconazole Impurity 63 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 known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. Our supply guarantees the reliability and consistency essential for these demanding applications.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Posaconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for stability studies and degradation pathway profiling of Posaconazole formulations.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, providing necessary impurity data.
• Valuable for pharmacological and toxicological research to understand the impact of specific impurities.
• Serves as a calibration standard in mass spectrometry and other advanced analytical techniques.

Basic Information

Product Name	Posaconazole Impurity 63
CAS No.	208187-15-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 63; Posaconazole EP Impurity C; Posaconazole USP 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; SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 63 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines (Q3A, Q3B) and pharmacopeial standards (USP, EP) for impurities.

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 dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator or equivalent low-humidity environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.