Description

Arbidol Impurity 11 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 of related substances. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance for Arbidol/Umifenovir.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Arbidol (Umifenovir) active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Arbidol batches meet stringent pharmacopeial (e.g., USP, EP) or internal specifications for impurity limits.
• Stability Studies: Employed to identify and track degradation products that may form in Arbidol formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and process chemistry research to understand and minimize the formation of this specific impurity during Arbidol manufacturing.

Basic Information

Product Name	Arbidol Impurity 11
CAS No.	1312943-27-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Umifenovir Impurity 11; Arbidol Related Compound 11; Ethyl 6-bromo-4-[(dimethylamino)methyl]-5-hydroxy-1-methyl-2-[(phenylsulfanyl)methyl]-1H-indole-3-carboxylate; 1312943-27-3; Arbidol EP Impurity J; Arbidol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Arbidol Impurity 11 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, 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 for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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