Description

Remdesivir Impurity 39 is a high-purity reference standard used in the analytical characterization and quality control of the antiviral drug Remdesivir. This impurity is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams working on antiviral therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Remdesivir Impurity 39 in drug substance and drug product.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Supports process chemistry optimization by helping to understand and control impurity formation during synthesis.

Basic Information

Product Name	Remdesivir Impurity 39
CAS No.	1911579-04-8
Molecular Formula	C27H35N6O8P
Molecular Weight	602.58 g/mol
Synonyms	GS-5734 Impurity 39; (2R,3S,4R,5R)-2-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-((S)-(((2R,3S,4R,5R)-5-(4-cyanopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(phenoxy)phosphorylamino)-3,4-dihydroxytetrahydrofuran-3-yl hydrogen phosphate; Remdesivir Related Compound 39; Veklury Impurity 39; Remdesivir Degradant 39; GS-441524 Impurity (related); Remdesivir Process Impurity
EINECS	Contact for details

Quality Control

Our Remdesivir Impurity 39 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided, detailing results from HPLC, LC-MS, NMR, and other relevant tests. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.