Description

Ribavirin Impurity 7 is a designated reference standard used in the analytical profiling and quality control of the antiviral drug Ribavirin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ribavirin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability component and a quantitative marker in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis, purification, and scale-up of Ribavirin manufacturing processes.

Basic Information

Product Name	Ribavirin Impurity 7
CAS No.	39925-11-6
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; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide Impurity; Ribavirin EP Impurity G; Ribavirin USP Related Compound; 1,2,4-Triazole-3-carboxamide, 1-β-D-ribofuranosyl-; Virazole Impurity
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, chromatographic profile, and water content.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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