Description

Ribavirin Impurity E is a specified impurity of the broad-spectrum antiviral drug Ribavirin, used in pharmaceutical quality control and analytical research. This compound is critical for ensuring the purity, safety, and efficacy of Ribavirin drug substances and finished products through method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for impurity profiling, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ribavirin.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance: Serves as a system suitability standard in the routine QC testing of Ribavirin Active Pharmaceutical Ingredients (APIs) and formulations.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identification and characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Ribavirin.

Basic Information

Product Name	Ribavirin Impurity E
CAS No.	58151-90-9
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1-((2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide; Ribavirin Related Compound E; 1-β-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide Impurity; 3-Carbamoyl-1-β-D-ribofuranosyl-1,2,4-triazole; Ribavirin Degradant E
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity E is manufactured and controlled under a strict quality management system. The product 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 standard. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator 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)	≤ 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.