Description

Arbidol Impurity 21 is a high-purity chemical reference standard used in the 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 during analytical testing. 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 impurity standard for the analytical method development and validation of Umifenovir (Arbidol) API and finished drug products.
• Quality Control & Assurance: Essential for routine HPLC/LC-MS analysis to monitor and control impurity levels in drug substance batches, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Utilized in synthetic chemistry research to understand the formation pathways of this impurity and to optimize manufacturing processes to minimize its presence.

Basic Information

Product Name	Arbidol Impurity 21
CAS No.	1606173-86-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Umifenovir Impurity 21; Arbidol Related Compound 21; 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 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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