Description

Posaconazole Impurity 20 is a designated impurity standard used in the analytical profiling and quality control of the antifungal pharmaceutical, Posaconazole. This high-purity reference material is critical for ensuring drug safety and efficacy by enabling accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Posaconazole API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Posaconazole Active Pharmaceutical Ingredient (API).
• Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC testing of Posaconazole batches to ensure compliance with ICH guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and demonstrate control strategies.
• Research & Development: Supports process chemistry research aimed at understanding and minimizing the formation of this impurity during synthesis.

Basic Information

Product Name	Posaconazole Impurity 20
CAS No.	1229428-91-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 20; Posaconazole EP Impurity J; Posaconazole USP Impurity; Posaconazole Process 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 (IUPAC); SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 20 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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