Description

Ribavirin API Impurity O is a specified impurity of the antiviral drug Ribavirin, identified by the CAS Registry Number 799-87-1. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Ribavirin drug substances and products. It is primarily required by quality control and research & development teams in the pharmaceutical industry for analytical reference standards and method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity O in Ribavirin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, validating, and transferring high-performance liquid chromatography (HPLC) or other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Ribavirin formulations.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Process Chemistry Research: Used in research to understand the formation pathways of this impurity during the synthesis of Ribavirin, aiding in process optimization and impurity control.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability component and for routine batch release testing to ensure impurity profiles meet pharmacopeial (e.g., USP, EP) or internal specifications.

Basic Information

Product Name	Ribavirin API Impurity O
CAS No.	799-87-1
Molecular Formula	C8H12N4O5
Molecular Weight	244.20 g/mol
Synonyms	1-((2S,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide; Ribavirin Impurity O; 1-β-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide Impurity O; 3-Carbamoyl-1-β-D-ribofuranosyl-1,2,4-triazole Impurity O
EINECS	Contact for details

Quality Control

Every batch of Ribavirin API Impurity O is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.