Description

Arbidol Impurity 15 is a high-purity chemical reference standard used in the research, development, and quality control of the antiviral drug Umifenovir (Arbidol). This impurity is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling accurate identification and quantification of process-related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Arbidol Impurity 15 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the manufacturing process of Umifenovir (Arbidol).
• Quality Control & Assurance (QC/QA): A critical component in in-house quality control laboratories to ensure API purity meets pharmacopeia specifications (e.g., ICH Q3A, Q3B).
• Stability Studies: Employed to track the formation and level of this specific impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Used to generate data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Research & Development: Supports process chemistry research aimed at optimizing synthesis routes to minimize the formation of this impurity.

Basic Information

Product Name	Arbidol Impurity 15
CAS No.	25888-09-9
Molecular Formula	C22H25BrN2O3S
Molecular Weight	477.42 g/mol
Synonyms	Umifenovir Impurity 15; Arbidol Related Compound 15; Ethyl 6-bromo-4-[(dimethylamino)methyl]-5-hydroxy-1-methyl-2-[(phenylsulfanyl)methyl]-1H-indole-3-carboxylate; 6-Bromo-4-[(dimethylamino)methyl]-5-hydroxy-1-methyl-2-[(phenylthio)methyl]-1H-indole-3-carboxylic acid ethyl ester
EINECS	Contact for details

Quality Control

Every batch of Arbidol Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity and structural confirmation data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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