Description

Voriconazole Impurity 15 is a high-purity 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) Voriconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Voriconazole API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity levels throughout the drug lifecycle.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP-compliant manufacturing environments.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive characterization data for specified impurities as per ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Voriconazole.

Basic Information

Product Name	Voriconazole Impurity 15
CAS No.	321589-00-8
Molecular Formula	C16H14F3N5O
Molecular Weight	349.31 g/mol
Synonyms	Voriconazole Related Compound 15; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; UNII-1U8S5N8Q8F; 1U8S5N8Q8F; Voriconazole EP Impurity I; Voriconazole USP Related Compound A (Check for specific correlation); (αR,βS)-α-(2,4-Difluorophenyl)-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-5-fluoropyrimidine-4-ethanol
EINECS	Contact for details

Quality Control

Every batch of Voriconazole Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, aligning with current pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses 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 controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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