Description

Remdesivir Impurity-1 CAS NO 1355049-95-4 is a critical pharmaceutical reference standard used for the analytical characterization and quality control of the antiviral drug Remdesivir. This impurity is essential for ensuring drug safety and efficacy by enabling precise monitoring and control during the manufacturing process. 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: Serves as a certified impurity standard for the identification and quantification of related substances in Remdesivir active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability, specificity, and detection limits.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure Remdesivir meets stringent purity specifications as per ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and stability data.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions.
• Research & Development: Used in process chemistry research to understand and control impurity formation pathways during synthesis.

Basic Information

Product Name	Remdesivir Impurity-1
CAS No.	1355049-95-4
Molecular Formula	C27H35N6O8P
Molecular Weight	602.58 g/mol
Synonyms	GS-441524 Impurity; GS-5734 Impurity-1; (2R,3R,4R,5R)-2-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile; Remdesivir Related Compound 1; GS-441524 Monophosphate Impurity; Veklury Impurity-1; Remdesivir Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Remdesivir Impurity-1 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, LC-MS). A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere for long-term stability. For short-term use, the material may be stored at 2-8°C. The container should be allowed to reach room temperature before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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