Description

Remdesivir Impurity2 CAS NO 1355357-49-1 is a designated impurity standard used in the analytical profiling and quality control of the antiviral active pharmaceutical ingredient (API) Remdesivir. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of antiviral therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Remdesivir Impurity2 in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control (QC) Testing: Employed in routine QC testing of Remdesivir batches to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Supports process chemistry research aimed at understanding and minimizing the formation of this specific impurity during synthesis.

Basic Information

Product Name	Remdesivir Impurity2
CAS No.	1355357-49-1
Molecular Formula	C27H35N6O8P
Molecular Weight	602.58 g/mol
Synonyms	GS-441524 Impurity; GS-5734 Impurity 2; (2S)-2-{(2R,3S,4R,5R)-[5-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxy-tetrahydro-furan-2-ylmethoxy]phenoxy-(S)-phosphorylamino}propionic acid 2-ethylbutyl ester; Remdesivir Related Compound 2; Veklury Impurity 2; Remdesivir EP Impurity B; Remdesivir USP Impurity 2
EINECS	Contact for details

Quality Control

Our Remdesivir Impurity2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with pharmacopeial standards for impurity reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, LC-MS, NMR, and other relevant tests.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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