Description

Posaconazole Impurity 11 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 benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on active pharmaceutical ingredient (API) development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability testing of Posaconazole formulations.
• Research & Development: Facilitates studies on the degradation pathways, metabolism, and pharmacokinetics of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 11
CAS No.	2125943-81-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 11; Posaconazole Impurity; Posaconazole EP Impurity 11; Posaconazole USP Impurity 11; SCH 56592 Impurity 11; (2R,3S)-rel-2-(2,4-Difluorophenyl)-3-(5-{4-[(3R,5R)-5-{2R,4S)-2-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl}piperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (Impurity of Posaconazole)
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 11 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 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.