Description

Ribavirin Impurity M is a high-purity reference standard of a key process-related impurity in the antiviral drug Ribavirin. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

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 dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP manufacturing environments.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability studies of Ribavirin.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.

Basic Information

Product Name	Ribavirin Impurity M
CAS No.	50730-26-2
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 M; 1-β-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide Impurity; Ribavirin EP Impurity M; Ribavirin USP Related Compound M
EINECS	Contact for details

Quality Control

Our Ribavirin Impurity M is manufactured and tested under strict quality systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the analytical results and confirming compliance with in-house specifications aligned with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.