Description

Voriconazole Impurity 18 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Voriconazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Voriconazole API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC testing of Voriconazole batches to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Aids in synthetic route optimization and process chemistry by identifying and controlling this impurity during API manufacturing.

Basic Information

Product Name	Voriconazole Impurity 18
CAS No.	321588-94-7
Molecular Formula	C16H14F3N5O
Molecular Weight	349.31 g/mol
Synonyms	Voriconazole Related Compound 18; Voriconazole EP Impurity 18; Voriconazole USP Impurity 18; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; Voriconazole Process Impurity; VRC Impurity 18
EINECS	Contact for details

Quality Control

Our Voriconazole Impurity 18 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We adhere to relevant industry standards for reference materials to support your compliance with ICH, 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 label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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