Description

Ribavirin Impurity R CAS NO 415704-39-1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of the antiviral drug Ribavirin by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The availability of this well-characterized impurity is essential for method validation and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ribavirin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity during the manufacturing process of Ribavirin.
• Regulatory Submissions & Compliance: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to track the formation and level of this impurity over time in stability testing of Ribavirin formulations under various ICH-prescribed conditions.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and synthesis of Ribavirin.

Basic Information

Product Name	Ribavirin Impurity R
CAS No.	415704-39-1
Molecular Formula	C8H12N4O5
Molecular Weight	244.20 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 R; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide Impurity; Ribavirin EP Impurity R; Ribavirin USP Impurity R
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity R is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, aligning with pharmacopeial standards (USP/EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from HPLC purity assay, related substances, residual solvents, and other critical tests. Our quality commitment supports your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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