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Remdesivir Impurity CAS NO 1911578-74-9


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CAS No.:1911578-74-9

Grade:Pharmacy Grade

Content:99.9%

Brand:Customizable

Packaging:Customizable

Description

Remdesivir Impurity CAS NO 1911578-74-9 is a high-purity reference standard used in the analytical profiling and quality control of the antiviral drug Remdesivir. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on antiviral drug development and manufacturing.

Application

  • Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Remdesivir drug substance and drug product.
  • Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
  • Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
  • Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
  • Stability Studies: Employed to track the formation of degradation products under various stress conditions.
  • Process Chemistry R&D: Aids in the optimization of synthesis and purification processes to minimize impurity formation.

Basic Information

Product Name Remdesivir Impurity
CAS No. 1911578-74-9
Molecular Formula Contact for details
Molecular Weight Contact for details
Synonyms GS-441524 Impurity; Remdesivir Related Compound; GS-5734 Impurity; (2R,3S,4R,5R)-2-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile impurity; Veklury Impurity; SARS-CoV-2 therapeutic impurity; Nucleoside analog impurity
EINECS Contact for details

Quality Control

Every batch of Remdesivir Impurity CAS 1911578-74-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, NMR, MS) is provided with each shipment to support your regulatory and quality 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 material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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 unknown 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.

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