Description

Ribavirin Impurity F is a specified impurity of the broad-spectrum antiviral drug Ribavirin, used as a critical reference standard in pharmaceutical quality control. This compound is essential for ensuring the purity, safety, and efficacy of Ribavirin drug substances and finished products through precise analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance. The use of this well-characterized impurity standard is fundamental for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ribavirin Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control and Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory agencies like the FDA and EMA.
• Pharmacopeial Testing: Supports testing to meet the specifications outlined in monographs from the USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.

Basic Information

Product Name	Ribavirin Impurity F
CAS No.	58151-87-4
Molecular Formula	C8H12N4O5
Molecular Weight	244.20 g/mol
Synonyms	1-((2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide; Ribavirin Carboxamide; Ribavirin Related Compound F; Ribavirin Impurity 6; 1-(β-D-Ribofuranosyl)-1,2,4-triazole-3-carboxamide
EINECS	Contact for details

Quality Control

Our Ribavirin Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate characterization. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances. The quality standards align with the requirements for pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP guidelines. Certificates of Analysis (COA) are available upon request.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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