Description

Remdesivir Impurity 44 is a high-purity chemical reference standard used in the analytical characterization of the antiviral drug Remdesivir. This impurity is critical for pharmaceutical research and development, enabling the identification, quantification, and control of process-related substances to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory affairs, and analytical scientists working in pharmaceutical manufacturing and API development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Remdesivir.
• Method Development and Validation: Critical for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in QC laboratories.
• Impurity Profiling and Control: Used to establish impurity profiles, set specification limits, and monitor batch-to-batch consistency during API synthesis.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on identified impurities as per ICH guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research and Development: Facilitates process chemistry optimization by identifying and minimizing the formation of this impurity during synthesis.

Basic Information

Product Name	Remdesivir Impurity 44
CAS No.	2096990-00-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	GS-5734 Impurity 44; Remdesivir Related Compound 44; (2R,3S,4R,5R)-2-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile; Veklury Impurity 44; SARS-CoV-2 Therapeutic Impurity; Nucleoside Analog Impurity
EINECS	Contact for details

Quality Control

Our Remdesivir Impurity 44 is manufactured under strict quality systems to ensure the highest standards of purity and consistency, suitable for use in regulated environments. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR for structural confirmation and purity assessment. We adhere to relevant ICH guidelines for impurity characterization to support our clients' pharmaceutical development and quality control requirements.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to prevent degradation. Handle and store in accordance with good laboratory practices.

Specification

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

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