Description

Ribavirin Impurity 40 is a high-purity reference standard used in the analytical profiling and quality control of the antiviral drug Ribavirin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ribavirin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life specifications.
• Research & Development: Used in synthetic chemistry R&D to understand impurity formation pathways and develop purer synthesis routes for Ribavirin.

Basic Information

Item	Detail
Product Name	Ribavirin Impurity 40
CAS No.	39215-01-5
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1,2,4-Triazole-3-carboxamide, 5-(2,3,5-tri-O-benzoyl-β-D-ribofuranosyl)-; Ribavirin Related Compound; 2',3',5'-Tri-O-benzoylribavirin; 1-((2S,3R,4S,5R)-3,4-Bis(benzoyloxy)-5-(benzoyloxy)methyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide; Ribavirin Tribenzoate; Ribavirin Process Impurity; Virazole Impurity
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, NMR, and mass spectrometry to ensure they meet 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

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%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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