Description

Arbidol Impurity I CAS NO 153633-10-4 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and analytical validation of Umifenovir (Arbidol), an antiviral medication. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure drug purity, safety, and regulatory compliance. The availability of this well-characterized impurity standard is fundamental for method development and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Umifenovir (Arbidol) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., ICH Q3A/B guidelines).
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA, EMA, and NMPA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the parent drug.

Basic Information

Product Name	Arbidol Impurity I
CAS No.	153633-10-4
Molecular Formula	C22H25BrN2O3S
Molecular Weight	477.42 g/mol
Synonyms	Umifenovir Impurity I; Arbidol Related Compound I; 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; ARB Impurity I; UNII-9B6K4V3W8P
EINECS	Contact for details

Quality Control

Our Arbidol Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality standards align with ICH guidelines to support your regulatory requirements.

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 moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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