Description

Clofazimine Related Compound 2 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient clofazimine through precise analytical testing. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify impurities in clofazimine API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Indicating Method (SIM): Employed in forced degradation studies to monitor the stability of clofazimine formulations and understand degradation pathways.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) that specify impurity limits for clofazimine.
• Research on Anti-Mycobacterial Agents: Used in academic and industrial research studying the structure-activity relationships and metabolism of riminophenazine compounds like clofazimine.

Basic Information

Product Name	Clofazimine Related Compound 2
CAS No.	90712-89-3
Molecular Formula	C27H22Cl2N4
Molecular Weight	473.40 g/mol
Synonyms	2-(4-Chloroanilino)-5-(4-chlorophenyl)-3,5-dihydro-3-[(4-methylphenyl)imino]phenazin-2-amine; Clofazimine Impurity 2; Clofazimine Related Substance 2; Clofazimine EP Impurity B; Clofazimine USP Related Compound B; N,N'-Bis(4-chlorophenyl)-3,4-diamino-2-methylphenazine; Lamprene Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Clofazimine Related Compound 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	Orange to red powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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