Description

Voriconazole Impurity 53 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 Voriconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Voriconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Voriconazole formulations to understand degradation pathways.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to health authorities like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during the manufacturing process.

Basic Information

Item	Detail
Product Name	Voriconazole Impurity 53
CAS No.	1702684-04-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Voriconazole Related Compound 53; Voriconazole EP Impurity G; Voriconazole USP Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; UNII-Contact for details; Voriconazole Degradation Product; Voriconazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Voriconazole Impurity 53 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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