Description

Posaconazole Impurity 19 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 needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The use of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Posaconazole API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for conducting stability studies and degradation pathway profiling of Posaconazole drug products.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, supporting impurity qualification reports.
• Valuable material for pharmaceutical research into the synthesis, metabolism, and degradation chemistry of triazole antifungals.
• Serves as a calibration standard in mass spectrometry and other advanced analytical techniques.

Basic Information

Product Name	Posaconazole Impurity 19
CAS No.	201282-88-4
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Related Compound 19; Posaconazole EP Impurity J; 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 19 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity confirmation, and impurity profile. We support compliance with USP, EP, and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.