Description

Ribavirin Impurity 38 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiviral drug Ribavirin through precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The product is supplied with comprehensive analytical data to support method validation and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Primary use 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: Critical for developing, validating, and verifying HPLC, UPLC, and LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Stability Studies: Employed to track the formation of degradation products in Ribavirin under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Research & Development: Facilitates research into the metabolism, degradation pathways, and synthesis of Ribavirin and its related compounds.

Basic Information

Product Name	Ribavirin Impurity 38
CAS No.	130792-81-3
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1-(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,2,4-triazole-3-carboxamide; Ribavirin Related Compound 38; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide Impurity; Ribavirin Degradant; Virazole Impurity 38; 1-(β-D-Ribofuranosyl)-1H-1,2,4-triazole-3-carboxamide; RTCA Impurity
EINECS	Contact for details

Quality Control

Every batch of Ribavirin Impurity 38 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP, ChP).

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 storing under an inert atmosphere (e.g., argon or nitrogen) in a desiccator.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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