Description

Arbidol Impurity 14 is a high-purity chemical reference standard used in the analytical characterization and quality control of the antiviral drug Umifenovir (Arbidol). This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and routine testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Umifenovir (Arbidol) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and purity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Arbidol to understand degradation pathways and establish shelf-life.
• Research & Development: Used in synthetic chemistry R&D for process optimization and impurity profiling during scale-up.

Basic Information

Product Name	Arbidol Impurity 14
CAS No.	1332614-17-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Umifenovir Impurity 14; Arbidol Related Compound 14; 1-Methyl-2-((phenylthio)methyl)-3-carboxy-4-(dimethylaminomethyl)-5-hydroxy-6-bromoindole (tentative, based on naming conventions); ARB Impurity 14; 1332614-17-1; UNII-Not Assigned; Arbidol Process Impurity
EINECS	Contact for details

Quality Control

Our Arbidol Impurity 14 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 absorption of moisture. For long-term storage, consider desiccants.

Specification

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

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