Description

Ribavirin Impurity 55 is a designated reference standard used for the analytical profiling and quality control of the antiviral drug Ribavirin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development, validation, and routine testing of Ribavirin and its related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ribavirin Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to ensure Ribavirin batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Ribavirin formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and control process-related impurities.

Basic Information

Item	Details
Product Name	Ribavirin Impurity 55
CAS No.	119240-35-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ribavirin Related Compound 55; Ribavirin Impurity F; 1-((2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide impurity; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide Impurity 55; Ribavirin EP Impurity F; Ribavirin USP Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity 55 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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