Description

Voriconazole Impurity 7 is a specified impurity and degradation product of the antifungal active pharmaceutical ingredient (API) Voriconazole. This compound is critical for pharmaceutical research, development, and quality control, serving as a reference standard to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries for method validation, stability studies, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Voriconazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during manufacturing and stability testing.
• Quality Control & Batch Release: Employed in routine QC testing to ensure drug substance and product batches comply with stringent pharmacopeial (USP, EP, ICH) impurity limits.
• Stability Studies & Forced Degradation: Acts as a marker to understand degradation pathways and establish shelf-life specifications for Voriconazole formulations.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Metabolism & Degradation: Utilized in research settings to study the metabolic pathways and chemical stability of Voriconazole.

Basic Information

Product Name	Voriconazole Impurity 7
CAS No.	239807-04-6
Molecular Formula	C16H14F3N5O
Molecular Weight	349.31 g/mol
Synonyms	Voriconazole Related Compound 7; Voriconazole EP Impurity 7; Voriconazole USP Impurity 7; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; Voriconazole Degradation Product; VRC Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Voriconazole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
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.