Description

Posaconazole Impurity 35 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 active pharmaceutical ingredient (API) Posaconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Posaconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure Posaconazole meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Posaconazole formulations under various storage conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the impurity profile and degradation pathways of Posaconazole.

Basic Information

Item	Details
Product Name	Posaconazole Impurity 35
CAS No.	1370190-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 35; Posaconazole Impurity C; Posaconazole EP Impurity C; Posaconazole USP Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{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}-1,2,4-oxadiazol-3-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol; SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic methods. We support GMP-grade requirements for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown 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.