Description

Ribavirin Impurity CAS NO 88947-31-3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the antiviral drug Ribavirin by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and manufacturing. The impurity standard supports compliance with stringent regulatory requirements for drug substance characterization.

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 and Validation: Used in developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Employed as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to monitor impurity levels.
• Stability Studies: Aids in the identification of degradation products formed during forced degradation and long-term stability studies of Ribavirin formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for the drug substance.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and track process-related impurities.

Basic Information

Product Name	Ribavirin Impurity
CAS No.	88947-31-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-((2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl)-1H-1,2,4-triazole-3-carboxamide; Ribavirin Related Compound; Ribavirin Impurity A (Potential); 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide Impurity; 3-Carbamoyl-1-β-D-ribofuranosyl-1,2,4-triazole; Virazole Impurity
EINECS	Contact for details

Quality Control

Our Ribavirin Impurity standard is manufactured under strict quality systems to ensure identity, purity, and consistency. Each batch is subjected to comprehensive analytical testing, including chromatographic purity (HPLC), spectroscopic identification (IR, NMR), and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards required for pharmaceutical reference materials, supporting your compliance with cGMP, ICH, and pharmacopeial (USP, EP) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

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

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