Description

Favipiravir Impurity 14 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiviral drug Favipiravir. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Favipiravir Impurity 14 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a critical tool in routine QC testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and metabolism of Favipiravir.

Basic Information

Product Name	Favipiravir Impurity 14
CAS No.	356783-49-8
Molecular Formula	C5H4FN3O2
Molecular Weight	157.10 g/mol
Synonyms	6-Fluoro-3-hydroxypyrazine-2-carboxamide; T-705 Impurity 14; Avigan Impurity 14; Favipiravir Related Compound 14; 3-Hydroxy-6-fluoropyrazine-2-carboxamide; 2-Pyrazinecarboxamide, 6-fluoro-3-hydroxy-; 6-Fluoro-3-hydroxy-2-pyrazinecarboxamide
EINECS	Contact for details

Quality Control

Our Favipiravir Impurity 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS, NMR) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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