Description

Arbidol Impurity 1 is a high-purity reference standard used in the analytical characterization and quality control of the antiviral drug Umifenovir (Arbidol). This impurity is critical for pharmaceutical development and manufacturing, ensuring product safety and regulatory compliance. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of Arbidol batches, supporting compliance with ICH, USP, and EP guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish drug shelf life.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies such as the FDA, EMA, and NMPA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purer synthetic routes for Umifenovir.

Basic Information

Product Name	Arbidol Impurity 1
CAS No.	1130901-04-0
Molecular Formula	C22H25BrN2O3S
Molecular Weight	477.42 g/mol
Synonyms	Umifenovir Impurity 1; Arbidol Related Compound 1; 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; Arbidol EP Impurity B; Arbidol USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Arbidol Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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