Description

α-Ribavirin (Ribavirin Impurity B) is a key impurity and reference standard used in the quality control of the antiviral drug Ribavirin. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations through precise analytical methods. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in antiviral drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ribavirin Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC labs.
• Regulatory Compliance & Documentation: Used to prepare impurity profiles and support regulatory filings (e.g., for FDA, EMA) to demonstrate product quality and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ribavirin to monitor impurity formation over time.
• Pharmaceutical Research: Utilized in research settings to study the metabolism, degradation pathways, and pharmacological activity of Ribavirin-related compounds.
• Quality Assurance/Quality Control (QA/QC): A critical component for in-process testing and release testing of Ribavirin batches to ensure they meet stringent pharmacopeial specifications.

Basic Information

Product Name	α-Ribavirin (Ribavirin Impurity B)
CAS No.	57198-02-4
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide; Ribavirin Impurity B; Ribavirin Related Compound B; 1-(β-D-Ribofuranosyl)-1,2,4-triazole-3-carboxamide; Virazole Impurity B; NSC 163039; RTB; α-Ribavirin
EINECS	Contact for details

Quality Control

Our α-Ribavirin (Ribavirin Impurity B) is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure 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
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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